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CompletedNCT00530790Updated Sep 26, 2018Results posted

Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome

A Phase 2 interventional study of ropinirole controlled release (CR)-RLS in Restless Legs Syndrome, sponsored by GlaxoSmithKline. Completed at 11 sites in Japan. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2018-09-26.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
18 Years to 79 Years
Sex
All
01

Study summary

This study was designed to evaluate the safety, pharmacokinetic profile and efficacy in Restless Legs Syndrome patients.

02

Conditions studied

  • Restless Legs Syndrome

Keywords

  • Restless Legs Syndrome
03

In context

Restless Legs Syndrome

254 studies on the registry are indexed under Restless Legs Syndrome; 39 are open to participants now.

This study's enrollment of 35 is below the median of 54 across 201 interventional studies indexed under Restless Legs Syndrome.

Browse Restless Legs Syndrome studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:

At Week -1 (at the start of Screening period)

  • Patients who are diagnosed with RLS according to the International RLS Study Group's (IRLSSG) Diagnostic Criteria.
  • Age: Patients aged at least 18 years and under 80 years.
  • Patients who have had RLS symptoms in the evening or nighttime (17:00 to 7:00 next day) for at least 20 days within one month before the start of the screening period. Patients treated for RLS before the start of the Screening period and who do not meet this criterion are considered eligible if the previous therapy can be discontinued from the Screening period.
  • Patients who experience RLS symptoms requiring treatment after 17:00 but prior to bedtime.

  • Gender: male and female Female of child-bearing potential will be eligible for inclusion in this study. However they must have a negative pregnancy test at the Screening visit. They agree are perform pregnancy test at the time determined and practice one of the following method of contraception from the Screening visit till the end of follow-up examination.

    • Abstinence
    • Oral Contraceptive, either combined or progestogen alone
    • Injectable progestogen
    • Implants of levonorgestrel
    • Estrogenic vaginal ring
    • Percutaneous contraceptive patches
    • Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label
    • Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject
    • Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus spermicidal agent (foam /gel / film / cream / suppository
  • Inpatient or outpatient status: Outpatient status
  • Patients who are able to give informed written consent in person. For patients aged under 20 years, their legally acceptable representatives are able to give informed written consent.

At Week 0 (at the start of treatment period)

  • Patients who experience RLS symptoms in the evening and nighttime (17:00 to 7:00 next day) for at least 4 days within 7 days before the start of the treatment period.
  • Patients who have sleep impairment associated with RLS. Patients who answered as 3 (severe) or 4 (very severe) to Question 4 (Sleep disturbance) in the IRLS Rating Scale
  • Patients whose IRLS Rating Scale total scores are 15 points or more.

Exclusion criteria

Exclusion Criteria:

  • Patients requiring treatment for daytime RLS symptoms (7:00 to 17:00).
  • Patients with signs of secondary RLS (e.g. chronic renal failure, iron-deficiency anemia, pregnancy, rheumatoid arthritis and Parkinson's disease).
  • Patients whose serum ferritin level is \<10 μg/L (ng/mL) at the start of Screening period.
  • Patients with following sleep disorder not associated with RLS e.g. narcolepsy, sleep terror disorder, sleep walking disorder, breathing related sleep disorder (Patients with obvious apnea in nighttime sleeping when they do not have alcohol drinking or over 15 times/hour is used to a target for apnea hypopnea index,in which case to implement polysomnography), etc.
  • Patients with complication of movement disorder (e.g. Parkinson's disease, dyskinesia, dystonia, etc.).
  • Patients with severe hepatic/renal/cardiac/pulmonary disorder or hematopoietic disorder.

The severity refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences" (Pharmaceutical affairs Bureau/Safety Division (PAB/SD) Notification No. 80, dated 29 June 1992).

  • Patients with the medical history or complication of cancer or malignant tumour.
  • Patients with the medical history or complication of substance abuse (e.g. alcohol or drug) or dependency of substance for the last one year
  • Patients whose diastolic blood pressure (BP) is >110 mmHg or \<50 mmHg or whose systolic BP is >180 mmHg or \<90 mmHg at the start of Screening period and Week0.
  • Patients intolerant for ropinirole hydrochloride (HCl) or other dopamine agonists.
  • Patients with the medical history of allergy to ropinirole HCl in the past.
  • Patients with the medical history of Augmentation to ropinirole HCl or other dopamine agonists in the past and those who have experienced early morning RLS symptoms.

Augmentation is defined as below:

RLS appear 2 hours earlier than the pre-treatment. Symptoms become severer than the pre-treatment. Symptoms which start after less time at rest than they did before treatment. The RLS extend to other sites (e.g. arm and trunk).

  • Patients without nighttime sleeping habit (e.g. night-shift worker, etc.) and those who must drastically change the habitual bedtime during the study duration.
  • Patients who have participated in another clinical study of an investigational product or medical device within the last 12 weeks prior to the start of screening period.
  • Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study .
  • Patients with chronic hepatitis typeB and /or typeC which is positive of hepatitis B surface antigen （HBsAg）and/or hepatitis C antibody.
  • Patients who have medical conditions which, in the opinion of investigator could affect efficacy and safety assessment. This may include, but are not limited to the following disorders: diabetes, peripheral neuropathy, fibromyalgia syndrome, symptomatic orthostatic hypotension, hepatic or renal failure, pleuro-pulmonary fibrosis.
  • Patients who have received treatment of an estrogen drug product and a drug that are known to substantially inhibit CYP1A2 and have changed the dose from baseline visit to Week 0.
  • Others whom the investigator (sub investigator) considers ineligible for the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    ropinirole CR-RLS

    Subjects will orally take ropinirole CR-RLS tablet(s) once daily 1-2 hours before the onset of RLS symptoms at about the same time of the day. The time of taking ropinirole must be after 16:00.Adjustment of the Ropinirole CR-RLS tablets should be completed after the Week 1 visit up to the Week 10 visit. The dose will be increased at intervals of at least one week until sufficient efficacy is obtained (use "much improved" as a guide) without safety problem. Dose escalation will start at the initial dose 0.5 mg/day to 1 mg/day; after 1 mg/day, the dose will be increased by 1 mg/day to the maximum 6 mg/day.

    Drug: ropinirole controlled release (CR)-RLS

Interventions

  • Drugropinirole controlled release (CR)-RLS

    White film-coated round-shaped tablet

    Also known as: Ropinirole CR-RLS (SK&F101468)

06

What researchers measure

Primary outcomes

  1. Drug Related Adverse Events-On-Therapy

    Time frame: Weeks 1 - 12 Treatment Period

  2. Haematology Clinical Lab Values Change From Baseline

    Standard units of measure vary. Therefore, Mean Change is represented in Standard Units: Hematocrit = SI unit of GSK; Hemoglobin = G/L; Platelet count, White Blood Cell count = GI/L; Red Blood Cell count = TI/L. n = number of subjects evaluated. EW = Early Withdrawal.

    Time frame: Baseline - Week 13 (Follow-up)

  3. Blood Chemistry Clinical Lab Values Change From Baseline

    Mean Change in Standard Units of Measure: Albumin, Total Protein=G/L; Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Lactate Dehydrogenase, Creatine Phosphokinase, Gamma Glutamyl Transferase=IU/L; Total Bilirubin, Creatinine=UMOL/L; Blood Urea Nitrogen, Cholesterol, Chloride, Sodium, Potassium=MMOL/L; Prolactin=MCG/L

    Time frame: Baseline - Week 13 (Follow-up)

  4. Urinalysis Clinical Lab Values

    Dipstick test values: Neg Value, Trace, +1, +2, +3. No subjects tested higher than +3.

    Time frame: Baseline - Week 13 (Follow-up)

  5. 12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline

    Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.

    Time frame: Baseline, Week 4, 8, 12, 13 (Follow-up)

  6. Vital Signs and Body Weight Change From Baseline

    Units of Measure Vary: Weight = kg; Semi-supine and Standing Systolic and Diastolic BP = mmHg; Semi-supine and Standing Pulse Rate = bpm; EW = early withdrawal; Semi-supine = lying down; Orthostatic = lying, sitting, and standing.

    Time frame: Baseline to Week 12/EW

Secondary outcomes

  1. Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score

    The IRLS Scale assesses the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood. The questionnaire scores various questions and totals them using the following scale: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, Mild=1-10 points, None=0 points.

    Time frame: Baseline and after Week 12

  2. Clinical Global Impression Scale - Severity of Illness (CGI-S)

    The CGI-S scale measures the overall severity of illness on a 7 point scale. Normal = 1, Borderline = 2, Mildly = 3, Moderately = 4, Markedly = 5, Severely = 6, Extremely Severe = 7(no subjects scored a 7).

    Time frame: Baseline - Final assessment point

  3. Clinical Global Impression Global Improvement (CGI-GI)

    CGI-GI is a 7 point scale assessing Global Improvement. 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse (no patients scored a 5, 6, or 7).

    Time frame: Baseline - Final assessment point

  4. Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score

    The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score \> 5 is considered to be suggestive of significant sleep disturbance.

    Time frame: Baseline - Week 12/EW

  5. Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains

    The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score \> 5 is considered to be suggestive of significant sleep disturbance.

    Time frame: Baseline - Week 12/EW

  6. Change From Baseline at Week 12/Early Withdrawal (EW) in Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire (RLSQOL) on the Overall Life Impact Score

    The RLSQOL scale consists of 18 items, 13 of which are scored on a 5-point scale. Ten of the items can be summed to the overall life impact score, which can be transformed to a 0-100 score. Mild = 84.48, Moderate = 62.93, or Severe = 37.47

    Time frame: Baseline and Week 12/EW

  7. Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS)

    The POMS Standard form contains 65 items (0-232). The respondent rates each item on a 5-point scale, ranging from "Not at all (0)" to "Extremely (4)." The assessment measures six identified mood factors: * Tension-Anxiety * Depression-Dejection * Anger-Hostility * Vigor-Activity * Fatigue-Inertia * Confusion-Bewilderment

    Time frame: Baseline and Week 12/EW

  8. Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)

    Self screening questionnaire that requires the first response to questions. Questionnaire consists of 14 questions, seven for anxiety "0-21" and seven for depression "0-21". Questions are answered on a four point scale from 0-3; Items 1, 3, 5, 6, 8, 10, 11, and 13 are reversed for summation.

    Time frame: Baseline - Week 12/EW

  9. Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.

    Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK\&101468 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.

    Time frame: Weeks 1-12

  10. Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.

    Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK\&104557 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.

    Time frame: Weeks 1 -12

  11. Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.

    Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK\&89124 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.

    Time frame: Weeks 1-12

07

Results

Posted Jul 24, 2009

Participant flow

Participant flow — Overall Study
MilestoneRopinirole CR-RLS
Started35
Completed30
Not completed5
Withdrew: Adverse event2
Withdrew: Withdrawal by subject2
Withdrew: Physician decision1

Outcome measures

PrimaryDrug Related Adverse Events-On-Therapy
Time frame:
Weeks 1 - 12 Treatment Period
Reported as:
Number · Number of Events
Drug Related Adverse Events-On-Therapy
Number of EventsRopinirole CR-RLS
Subjects with any Adverse Events29
Nausea14
Somnolence5
Vomiting5
Hypersomnia3
Diarrhea2
Dizziness2
Dyspepsia2
Fatigue2
Stomach discomfort2
Abdominal pain1
Anemia1
Insomnia1
Irritability1
Malaise1
Middle Insomnia1
Motion Sickness1
Palpitations1
Thirst1
SecondaryChange From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score

The IRLS Scale assesses the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood. The questionnaire scores various questions and totals them using the following scale: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, Mild=1-10 points, None=0 points.

Time frame:
Baseline and after Week 12
Reported as:
Mean · Points on a scale
Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score
Points on a scaleRopinirole CR-RLS
IRLS assessment Score - week 025.3 ± 4.42
IRLS assessment Score - week 126.0 ± 7.5
Change from Baseline at week 12-19.3 ± 7.68
SecondaryClinical Global Impression Scale - Severity of Illness (CGI-S)

The CGI-S scale measures the overall severity of illness on a 7 point scale. Normal = 1, Borderline = 2, Mildly = 3, Moderately = 4, Markedly = 5, Severely = 6, Extremely Severe = 7(no subjects scored a 7).

Time frame:
Baseline - Final assessment point
Reported as:
Number · Participants
Clinical Global Impression Scale - Severity of Illness (CGI-S)
ParticipantsRopinirole CR-RLS
Baseline - Normal0
Baseline - Borderline0
Baseline - Mildly0
Baseline - Moderately13
Baseline - Markedly13
Baseline - Severely9
Week 1 - Normal0
Week 1 - Borderline3
Week 1 - Mildly10
Week 1 - Moderately16
Week 1 - Markedly4
Week 1 - Severely2
Week 2 - Normal3
Week 2 - Borderline7
Week 2 - Mildly12
Week 2 - Moderately10
Week 2 - Markedly2
Week 2 - Severely1
Week 3 - Normal11
Week 3 - Borderline7
Week 3 - Mildly8
Week 3 - Moderately7
Week 3 - Markedly1
Week 3 - Severely1
Week 4 - Normal9
Week 4 - Borderline9
Week 4 - Mildly10
Week 4 - Moderately5
Week 4 - Markedly1
Week 4 - Severely1
Week 5 - Normal11
Week 5 - Borderline6
Week 5 - Mildly11
Week 5 - Moderately4
Week 5 - Markedly1
Week 5 - Severely0
Week 6 - Normal13
Week 6 - Borderline4
Week 6 - Mildly11
Week 6 - Moderately4
Week 6 - Markedly1
Week 6 - Severely0
Week 8 - Normal10
Week 8 - Borderline10
Week 8 - Mildly8
Week 8 - Moderately3
Week 8 - Markedly1
Week 8 - Severely0
Week 10 - Normal15
Week 10 - Borderline5
Week 10 - Mildly8
Week 10 - Moderately1
Week 10 - Markedly1
Week 10 - Severely0
Week 12 - Normal16
Week 12 - Borderline3
Week 12 - Mildly10
Week 12 - Moderately0
Week 12 - Markedly1
Week 12 - Severely0
Final assessment point - Normal17
Final assessment point - Borderline3
Final assessment point - Mildly12
Final assessment point - Moderately1
Final assessment point - Markedly1
Final assessment point - Severely1
SecondaryClinical Global Impression Global Improvement (CGI-GI)

CGI-GI is a 7 point scale assessing Global Improvement. 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse (no patients scored a 5, 6, or 7).

Time frame:
Baseline - Final assessment point
Reported as:
Number · Participants
Clinical Global Impression Global Improvement (CGI-GI)
ParticipantsRopinirole CR-RLS
Week 1 - Very Much Improved4
Week 1 - Much Improved12
Week 1 - Minimally Improved13
Week 1 - No Change6
Week 2 - Very Much Improved15
Week 2 - Much Improved9
Week 2 - Minimally Improved9
Week 2 - No Change2
Week 3 - Very Much Improved21
Week 3 - Much Improved7
Week 3 - Minimally Improved6
Week 3 - No Change1
Week 4 - Very Much Improved21
Week 4 - Much Improved7
Week 4 - Minimally Improved6
Week 4 - No Change1
Week 5 - Very Much Improved21
Week 5 - Much Improved6
Week 5 - Minimally Improved6
Week 5 - No Change0
Week 6 - Very Much Improved22
Week 6 - Much Improved7
Week 6 - Minimally Improved4
Week 6 - No Change0
Week 8 - Very Much Improved24
Week 8 - Much Improved6
Week 8 - Minimally Improved2
Week 8 - No Change0
Week 10 - Very Much Improved22
Week 10 - Much Improved6
Week 10 - Minimally Improved2
Week 10 - No Change0
Week 12 - Very Much Improved25
Week 12 - Much Improved4
Week 12 - Minimally Improved0
Week 12 - No Change1
Final assessment point - Very Much Improved27
Final assessment point - Much Improved5
Final assessment point - Minimally Improved1
Final assessment point - No Change2
SecondaryChange From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score

The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score \> 5 is considered to be suggestive of significant sleep disturbance.

Time frame:
Baseline - Week 12/EW
Reported as:
Mean · Points on a scale
Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score
Points on a scaleRopinirole CR-RLS
PSQI Total Score at Baseline9.4 ± 3.20
PSQI Total Score at Week 12/EW5.4 ± 2.89
Change from Baseline at Week 12/EW-4.2 ± 3.94
SecondaryChange From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains

The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score \> 5 is considered to be suggestive of significant sleep disturbance.

Time frame:
Baseline - Week 12/EW
Reported as:
Mean · Points on a scale
Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains
Points on a scaleRopinirole CR-RLS
Sleep Quality - Baseline2.0 ± 0.62
Sleep Quality - Week 12/EW1.2 ± 0.77
Sleep Quality - Change from Baseline-0.9 ± 0.78
Duration getting to sleep - Baseline2.0 ± 1.04
Duration getting to sleep - Week 12/EW1.0 ± 0.88
Duration getting to sleep - Change from Baseline-1.1 ± 1.09
Sleep Duration - Baseline1.9 ± 0.77
Sleep Duration - Week 12/EW1.5 ± 0.79
Sleep Duration - Change from Baseline-0.4 ± 0.74
Sleep Adequacy - Baseline0.9 ± 1.11
Sleep Adequacy - Week 12/EW0.4 ± 0.70
Sleep Adequacy - Change from Baseline-0.6 ± 1.19
Sleep Disturbance - Baseline1.2 ± 0.43
Sleep Disturbance - Week 12/EW0.9 ± 0.55
Sleep Disturbance - Change from Baseline-0.3 ± 0.60
Use of Sleeping pill - Baseline0.4 ± 1.01
Use of Sleeping pill - Week 12/EW0.0 ± 0.00
Use of Sleeping pill - Change from Baseline-0.4 ± 1.03
Somnolence - Baseline1.0 ± 0.92
Somnolence - Week 12/EW0.5 ± 0.62
Somnolence - Change from Baseline-0.5 ± 0.97
SecondaryChange From Baseline at Week 12/Early Withdrawal (EW) in Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire (RLSQOL) on the Overall Life Impact Score

The RLSQOL scale consists of 18 items, 13 of which are scored on a 5-point scale. Ten of the items can be summed to the overall life impact score, which can be transformed to a 0-100 score. Mild = 84.48, Moderate = 62.93, or Severe = 37.47

Time frame:
Baseline and Week 12/EW
Reported as:
Mean · Points on a scale
Change From Baseline at Week 12/Early Withdrawal (EW) in Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire (RLSQOL) on the Overall Life Impact Score
Points on a scaleRopinirole CR-RLS
RLSQOL Overall Life Impact Score - Baseline65.29 ± 14.499
RLSQOL Overall Life Impact Score - Week 1289.09 ± 13.431
Change from Baseline23.94 ± 16.759
PrimaryHaematology Clinical Lab Values Change From Baseline

Standard units of measure vary. Therefore, Mean Change is represented in Standard Units: Hematocrit = SI unit of GSK; Hemoglobin = G/L; Platelet count, White Blood Cell count = GI/L; Red Blood Cell count = TI/L. n = number of subjects evaluated. EW = Early Withdrawal.

Time frame:
Baseline - Week 13 (Follow-up)
Reported as:
Mean · Varied Standard Units of Measure
Haematology Clinical Lab Values Change From Baseline
Varied Standard Units of MeasureRopinirole CR-RLS
Hemoglobin (G/L) - week 4-1.2 ± 6.97
Hemoglobin (G/L) - week 8-2.7 ± 8.79
Hemoglobin (G/L) - week 12-1.0 ± 4.84
Hemoglobin (G/L) - week 12/EW-0.8 ± 4.69
Hemoglobin (G/L)- week 13-2.2 ± 7.30
Hematocrit (SI) - week 4-0.0033 ± 0.01972
Hematocrit (SI) - week 8-0.0074 ± 0.02470
Hematocrit (SI) - week 12-0.0021 ± 0.01174
Hematocrit (SI) - week 12/EW-0.0016 ± 0.01148
Hematocrit (SI) - week 13-0.0063 ± 0.01929
Platelet Count (GI/L) - week 414.5 ± 26.86
Platelet Count (GI/L) - week 811.7 ± 27.92
Platelet Count (GI/L) - week 128.5 ± 22.79
Platelet Count (GI/L) - week 12/EW8.8 ± 21.74
Platelet Count (GI/L) - week 1310.7 ± 41.48
Red Blood Cell Count (TI/L) - week 4-0.043 ± 0.2139
Red Blood Cell Count (TI/L) - week 8-0.084 ± 0.2701
Red Blood Cell Count (TI/L) - week 12-0.015 ± 0.1469
Red Blood Cell Count (TI/L) - week 12/EW-0.011 ± 0.1411
Red Blood Cell Count (TI/L) - week 13-0.050 ± 0.2140
White Blood Cell Count (GI/L) - week 4-0.191 ± 1.1655
White Blood Cell Count (GI/L) - week 8-0.268 ± 1.8694
White Blood Cell Count (GI/L) - week 12-0.577 ± 1.4972
White Blood Cell Count (GI/L) - week 12/EW-0.516 ± 1.4407
White Blood Cell Count (GI/L) - week 13-0.624 ± 1.4914
PrimaryBlood Chemistry Clinical Lab Values Change From Baseline

Mean Change in Standard Units of Measure: Albumin, Total Protein=G/L; Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Lactate Dehydrogenase, Creatine Phosphokinase, Gamma Glutamyl Transferase=IU/L; Total Bilirubin, Creatinine=UMOL/L; Blood Urea Nitrogen, Cholesterol, Chloride, Sodium, Potassium=MMOL/L; Prolactin=MCG/L

Time frame:
Baseline - Week 13 (Follow-up)
Reported as:
Mean · Varied Standard Units of Measure
Blood Chemistry Clinical Lab Values Change From Baseline
Varied Standard Units of MeasureRopinirole CR-RLS
Albumin (G/L) - week 4-1.0 ± 2.35
Albumin (G/L) - week 8-1.4 ± 2.64
Albumin (G/L) - week 12-0.7 ± 2.34
Albumin (G/L) - week 12/EW-0.6 ± 2.28
Albumin (G/L) - week 13-1.3 ± 2.33
Alkaline Phosphatase (IU/L) - week 45.2 ± 30.53
Alkaline Phosphatase (IU/L) - week 84.2 ± 26.94
Alkaline Phosphatase (IU/L) - week 1213.2 ± 29.35
Alkaline Phosphatase (IU/L) - week 12/EW13.4 ± 28.52
Alkaline Phosphatase (IU/L) - week 1316.0 ± 36.45
Alanine Amino Transferase (IU/L) - week 4-0.3 ± 3.80
Alanine Amino Transferase (IU/L) - week 8-0.7 ± 5.08
Alanine Amino Transferase (IU/L) - week 121.7 ± 4.66
Alanine Amino Transferase - week 12/EW1.8 ± 4.56
Alanine Amino Transferase - week 131.4 ± 6.36
Aspartate Amino Transferase(IU/L) - week 40.4 ± 4.55
Aspartate Amino Transferase (IU/L) - week 8-0.2 ± 4.07
Aspartate Amino Transferase (IU/L) - week 121.3 ± 4.57
Aspartate Amino Transferase (IU/L) - week 12/EW1.5 ± 4.51
Aspartate Amino Transferase (IU/L) - week 130.6 ± 4.35
Total Bilirubin (UMOL/L) - week 40.147 ± 3.1686
Total Bilirubin (UMOL/L) - week 8-0.588 ± 2.5180
Total Bilirubin (UMOL/L) - week 120.513 ± 3.4244
Total Bilirubin (UMOL/L) - week 12/EW0.311 ± 3.3513
Total Bilirubin (UMOL/L) - week 13-1.173 ± 3.7959
Blood Urea Nitrogen (MMOL/L) - week 4-0.14382 ± 1.079245
Blood Urea Nitrogen (MMOL/L) - week 8-0.06024 ± 0.862798
Blood Urea Nitrogen (MMOL/L) - week 120.25704 ± 1.076664
Blood Urea Nitrogen (MMOL/L) - week 12/EW0.30399 ± 1.043047
Blood Urea Nitrogen (MMOL/L) - week 130.32334 ± 0.974457
Cholesterol (MMOL/L) - week 4-0.093835 ± 0.5322345
Cholesterol (MMOL/L) - week 8-0.190717 ± 0.4337538
Cholesterol (MMOL/L) - week 120.151712 ± 0.5674075
Cholesterol (MMOL/L) - week 12/EW0.146540 ± 0.5494743
Cholesterol - week 13-0.107873 ± 0.5638668
Chloride(MMOL/L) - week 40.1 ± 1.78
Chloride (MMOL/L) - week 80.3 ± 2.07
Chloride (MMOL/L) - week 12-0.3 ± 1.81
Chloride (MMOL/L) - week 12/EW-0.2 ± 1.92
Chloride (MMOL/L) - week 13-0.1 ± 2.30
Lactate Dehydrogenase (IU/L) - week 40.3 ± 22.02
Lactate Dehydrogenase (IU/L) - week 8-1.3 ± 16.74
Lactate Dehydrogenase (IU/L) - week 122.0 ± 25.96
Lactate Dehydrogenase (IU/L) - week 12/EW2.7 ± 25.06
Lactate Dehydrogenase (IU/L) - week 13-2.2 ± 18.78
Sodium (MMOL/L) - week 4-0.4 ± 1.37
Sodium (MMOL/L) - week 8-0.2 ± 1.36
Sodium (MMOL/L) - week 120.0 ± 1.11
Sodium (MMOL/L) - week 12/EW-0.0 ± 1.07
Sodium (MMOL/L) - week 13-0.2 ± 1.29
Prolactin (MCG/L) - week 40.80 ± 7.003
Prolactin (MCG/L) - week 80.51 ± 7.229
Prolactin (MCG/L) - week 120.20 ± 6.770
Prolactin (MCG/L) - week 12/EW0.22 ± 6.466
Prolactin (MCG/L) - week 131.14 ± 7.144
Total Protein (G/L) - week 4-1.1 ± 3.73
Total Protein (G/L) - week 8-1.7 ± 4.03
Total Protein (G/L) - week 12-0.8 ± 3.32
Total Protein (G/L) - week 12/EW-0.8 ± 3.20
Total Protein (G/L) - week 13-2.2 ± 3.45
Creatine Phosphokinase (IU/L) - week 472.3 ± 533.72
Creatine Phosphokinase (IU/L) - week 8-15.8 ± 100.86
Creatine Phosphokinase (IU/L) - week 12-0.6 ± 115.92
Creatine Phosphokinase (IU/L) - week 12/EW-0.2 ± 110.40
Creatine Phosphokinase (IU/L) - week 13-1.9 ± 124.63
Creatinine (UMOL/L) - week 41.3134 ± 4.76710
Creatinine (UMOL/L) - week 80.5801 ± 7.23972
Creatinine (UMOL/L) - week 121.0019 ± 4.73343
Creatinine (UMOL/L) - week 12/EW1.0447 ± 4.60113
Creatinine (UMOL/L) - week 131.6417 ± 4.96904
Gamma Glutamyl Transferase (IU/L) - week 41.5 ± 17.56
Gamma Glutamyl Transferase (IU/L) - week 8-1.4 ± 11.68
Gamma Glutamyl Transferase (IU/L) - week 121.9 ± 14.56
Gamma Glutamyl Transferase (IU/L) - week 12/EW2.6 ± 14.26
Gamma Glutamyl Tranferase (IU/L) - week 130.1 ± 10.10
Potassium (MMOL/L) - week 40.07 ± 0.280
Potassium (MMOL/L) - week 80.05 ± 0.363
Potassium (MMOL/L) - week 120.09 ± 0.305
Potassium (MMOL/L) - week 12/EW0.10 ± 0.293
Potassium (MMOL/L) - week 130.06 ± 0.308
PrimaryUrinalysis Clinical Lab Values

Dipstick test values: Neg Value, Trace, +1, +2, +3. No subjects tested higher than +3.

Time frame:
Baseline - Week 13 (Follow-up)
Reported as:
Number · Participants
Urinalysis Clinical Lab Values
ParticipantsRopinirole CR-RLS
Urine Urobilinogen - Baseline: Neg Value0
Urine Urobilinogen - Baseline: Trace35
Urine Urobilinogen - Baseline: +10
Urine Urobilinogen - Baseline: +20
Urine Urobilinogen - Baseline: +30
Urine Urobilinogen - week 4: Neg Value0
Urine Urobilinogen - week 4: Trace35
Urine Urobilinogen - week 4: +10
Urine Urobilinogen - week 4: +20
Urine Urobilinogen - week 4: +30
Urine Urobilinogen - week 8: Neg Value0
Urine Urobilinogen - week 8: Trace32
Urine Urobilinogen - week 8: +10
Urine Urobilinogen - week 8: +20
Urine Urobilinogen - week 8: +30
Urine Urobilinogen - week 12: Neg Value0
Urine Urobilinogen - week 12: Trace30
Urine Urobilinogen - week 12: +10
Urine Urobilinogen - week 12: +20
Urine Urobilinogen - week 12: +30
Urine Urobilinogen - week 12/EW: Neg Value0
Urine Urobilinogen - week 12/EW: Trace33
Urine Urobilinogen - week 12/EW: +10
Urine Urobilinogen - week 12/EW: +20
Urine Urobilinogen - week 12/EW: +30
Urine Urobilinogen - week 13: Neg Value0
Urine Urobilinogen - week 13: Trace35
Urine Urobilinogen - week 13: +10
Urine Urobilinogen - week 13: +20
Urine Urobilinogen - week 13: +30
Urine Protein - Baseline: Neg Value34
Urine Protein - Baseline: Trace1
Urine Protein - Baseline: +10
Urine Protein - Baseline: +20
Urine Protein - Baseline: +30
Urine Protein - Week 4: Neg Value35
Urine Protein - Week 4: Trace0
Urine Protein - Week 4: +10
Urine Protein - Week 4: +20
Urine Protein - Week 4: +30
Urine Protein - Week 8: Neg Value31
Urine Protein - Week 8: Trace1
Urine Protein - Week 8: +10
Urine Protein - Week 8: +20
Urine Protein - Week 8: +30
Urine Protein - Week 12: Neg Value30
Urine Protein - Week 12: Trace0
Urine Protein - Week 12: +10
Urine Protein - Week 12: +20
Urine Protein - Week 12: +30
Urine Protein - Week 12/EW: Neg Value33
Urine Protein - Week 12/EW: Trace0
Urine Protein - Week 12/EW: +10
Urine Protein - Week 12/EW: +20
Urine Protein - Week 12/EW: +30
Urine Protein - Week 13: Neg Value35
Urine Protein - Week 13: Trace0
Urine Protein - Week 13: +10
Urine Protein - Week 13: +20
Urine Protein - Week 13: +30
Urine Occult Blood - Baseline: Neg Value27
Urine Occult Blood - Baseline: Trace5
Urine Occult Blood - Baseline: +13
Urine Occult Blood - Baseline: +20
Urine Occult Blood - Baseline: +30
Urine Occult Blood - Week 4: Neg Value20
Urine Occult Blood - Week 4: Trace7
Urine Occult Blood - Week 4: +16
Urine Occult Blood - Week 4: +22
Urine Occult Blood - Week 4: +30
Urine Occult Blood - Week 8: Neg Value25
Urine Occult Blood - Week 8: Trace3
Urine Occult Blood - Week 8: +13
Urine Occult Blood - Week 8: +20
Urine Occult Blood - Week 8: +31
Urine Occult Blood - Week 12: Neg Value23
Urine Occult Blood - Week 12: Trace4
Urine Occult Blood - Week 12: +12
Urine Occult Blood - Week 12: +21
Urine Occult Blood - Week 12: +30
Urine Occult Blood - Week 12/EW: Neg Value25
Urine Occult Blood - Week 12/EW: Trace5
Urine Occult Blood - Week 12/EW: +12
Urine Occult Blood - Week 12/EW: +21
Urine Occult Blood - Week 12/EW: +30
Urine Occult Blood - Week 13: Neg Value26
Urine Occult Blood - Week 13: Trace3
Urine Occult Blood - Week 13: +16
Urine Occult Blood - Week 13: +20
Urine Occult Blood - Week 13: +30
Urine Glucose - Baseline: Neg Value35
Urine Glucose - Baseline: Trace0
Urine Glucose - Baseline: +10
Urine Glucose - Baseline: +20
Urine Glucose - Baseline: +30
Urine Glucose - Week 4: Neg Value34
Urine Glucose - Week 4: Trace0
Urine Glucose - Week 4: +11
Urine Glucose - Week 4: +20
Urine Glucose - Week 4: +30
Urine Glucose - Week 8: Neg Value31
Urine Glucose - Week 8: Trace1
Urine Glucose - Week 8: +10
Urine Glucose - Week 8: +20
Urine Glucose - Week 8: +30
Urine Glucose - Week 12: Neg Value29
Urine Glucose - Week 12: Trace1
Urine Glucose - Week 12: +10
Urine Glucose - Week 12: +20
Urine Glucose - Week 12: +30
Urine Glucose - Week 12/EW: Neg Value32
Urine Glucose - Week 12/EW: Trace1
Urine Glucose - Week 12/EW: +10
Urine Glucose - Week 12/EW: +20
Urine Glucose - Week 12/EW: +30
Urine Glucose - Week 13: Neg Value35
Urine Glucose - Week 13: Trace0
Urine Glucose - Week 13: +10
Urine Glucose - Week 13: +20
Urine Glucose - Week 13: +30
Primary12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline

Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.

Time frame:
Baseline, Week 4, 8, 12, 13 (Follow-up)
Reported as:
Number · Participants
12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline
ParticipantsRopinirole CR-RLS
Baseline: N; Baseline: N29
Baseline: N; Baseline: ANCS0
Baseline: N; Baseline: ACS0
Baseline: ANCS; Baseline: N0
Baseline: ANCS; Baseline: ANCS5
Baseline: ANCS; Baseline: ACS0
Baseline: ACS; Baseline: N0
Baseline; ACS; Baseline: ANCS0
Baseline: ACS ; Baseline: ACS1
Baseline: N; Week 4: N27
Baseline: N; Week 4: ANCS1
Baseline: N; Week 4: ACS0
Baseline: ANCS; Week 4: N2
Baseline: ANCS; Week 4: ANCS1
Baseline: ANCS; Week 4: ACS1
Baseline: ACS; Week 4: N0
Baseline: ACS; Week 4: ANCS0
Baseline: ACS; Week 4: ACS1
Baseline: N; Week 8: N24
Baseline: N; Week 8: ANCS2
Baseline: N; Week 8: ACS0
Baseline: ANCS; Week 8: N2
Baseline: ANCS; Week 8: ANCS1
Baseline: ANCS; Week 8: ACS1
Baseline: ACS; Week 8: N0
Baseline: ACS; Week 8: ANCS1
Baseline: ACS; Week 8: ACS0
Baseline: N; Week 12/EW: N27
Baseline: N; Week 12/EW: ANCS0
Baseline: N; Week 12/EW: ACS0
Baseline: ANCS; Week 12/EW: N4
Baseline: ANCS; Week 12/EW: ANCS0
Baseline: ANCS; Week 12/EW: ACS1
Baseline: ACS; Week 12/EW: N0
Baseline: ACS; Week 12/EW: ANCS0
Baseline: ACS; Week 12/EW: ACS1
Baseline: N; Week 13: N27
Baseline: N; Week 13: ANCS2
Baseline: N; Week 13: ACS0
Baseline: ANCS; Week 13: N2
Baseline: ANCS; Week 13: ANCS2
Baseline: ANCS; Week 13: ACS1
Baseline: ACS; Week 13: N0
Baseline: ACS; Week 13: ANCS0
Baseline: ACS; Week 13: ACS1
PrimaryVital Signs and Body Weight Change From Baseline

Units of Measure Vary: Weight = kg; Semi-supine and Standing Systolic and Diastolic BP = mmHg; Semi-supine and Standing Pulse Rate = bpm; EW = early withdrawal; Semi-supine = lying down; Orthostatic = lying, sitting, and standing.

Time frame:
Baseline to Week 12/EW
Reported as:
Mean · Varied Standard Units of Measure
Vital Signs and Body Weight Change From Baseline
Varied Standard Units of MeasureRopinirole CR-RLS
Weight (Kg)0.5 ± 1.33
Semi-Supine Systolic BP (mmHg)2.7 ± 10.68
Semi-Supine Diastolic BP (mmHg)2.6 ± 7.25
Semi-Supine Pulse Rate (bpm)0.8 ± 9.11
Standing Systolic BP (mmHg)-0.7 ± 10.86
Standing Diastolic BP (mmHg)0.8 ± 7.64
Standing Pulse Rate (bpm)1.1 ± 9.94
Orthostatic Systolic BP (mmHg)-1.5 ± 8.50
Orthostatic Diastolic BP (mmHg)4.3 ± 5.58
Orthostatic Pulse Rate (bpm)9.2 ± 9.15
SecondaryChange From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS)

The POMS Standard form contains 65 items (0-232). The respondent rates each item on a 5-point scale, ranging from "Not at all (0)" to "Extremely (4)." The assessment measures six identified mood factors: * Tension-Anxiety * Depression-Dejection * Anger-Hostility * Vigor-Activity * Fatigue-Inertia * Confusion-Bewilderment

Time frame:
Baseline and Week 12/EW
Reported as:
Mean · Points on a scale
Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS)
Points on a scaleRopinirole CR-RLS
POMS - Baseline59.2 ± 21.59
POMS - Week 12/EW48.0 ± 18.69
Change from Baseline-10.4 ± 14.46
SecondaryChange From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)

Self screening questionnaire that requires the first response to questions. Questionnaire consists of 14 questions, seven for anxiety "0-21" and seven for depression "0-21". Questions are answered on a four point scale from 0-3; Items 1, 3, 5, 6, 8, 10, 11, and 13 are reversed for summation.

Time frame:
Baseline - Week 12/EW
Reported as:
Mean · Points on a scale
Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)
Points on a scaleRopinirole CR-RLS
Anxiety-HADS Anxiety Population - Baseline9.3 ± 1.50
Anxiety-HADS Anxiety Population - Week 12/EW7.7 ± 2.39
Change from Baseline for Anxiety Population-1.8 ± 2.58
Depression-HADS Depression Population -Baseline9.7 ± 1.42
Depression-HADS Depression Population-Week 12/EW9.5 ± 1.57
Change from Baseline for Depression Population-0.1 ± 1.77
SecondaryPharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.

Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK\&101468 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.

Time frame:
Weeks 1-12
Reported as:
Mean · picograms/mL
Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.
picograms/mLRopinirole CR-RLS
35 subjects who received 0.5 mg of Study drug310.01 ± 188.460
27subjects who received 1 mg of Study drug500.97 ± 293.344
11 subjects who received 2 mg of Study drug968.36 ± 696.327
2 subjects who received 3 mg of Study drug1294.55 ± 442.861
2 subjects who received 4 mg of Study drug1198.10 ± 362.463
SecondaryPharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.

Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK\&104557 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.

Time frame:
Weeks 1 -12
Reported as:
Mean · picograms/mL
Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.
picograms/mLRopinirole CR-RLS
35 subjects who received 0.5 mg of Study drug324.65 ± 134.576
27 subjects who received 1 mg of Study drug615.91 ± 259.145
11 subjects who received 2 mg of Study drug1320.31 ± 523.622
2 subjects who received 3 mg of Study drug1666.65 ± 325.764
2 subjects who received 4 mg of Study drug2541.95 ± 198.202
SecondaryPharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.

Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK\&89124 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.

Time frame:
Weeks 1-12
Reported as:
Mean · picograms/mL
Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.
picograms/mLRopinirole CR-RLS
2 subjects who received 0.5 mg of Study drug22.45 ± 3.465
11 subjects who received 1 mg of Study drug30.37 ± 10.227
11 subjects who received 2 mg of Study drug42.75 ± 17.286
2 subjects who received 3 mg of Study drug46.80 ± 8.202
2 subjects who received 4 mg of Study drug72.05 ± 2.051

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ropinirole CR-RLS—0/35 (0%)33/35 (94.3%)
Most frequent other events
Showing 10 of 47
Most frequent other events
EventRopinirole CR-RLS
NauseaGastrointestinal disorders15/35
NasopharyngitisRespiratory, thoracic and mediastinal disorders12/35
SomnolencePsychiatric disorders5/35
VomitingGastrointestinal disorders5/35
DizzinessGeneral disorders3/35
HypersomniaPsychiatric disorders3/35
AnemiaBlood and lymphatic system disorders2/35
ConstipationGastrointestinal disorders2/35
DiarrheaGastrointestinal disorders2/35
DyspepsiaGastrointestinal disorders2/35

Baseline characteristics

Age, Continuous
Age, Continuous(years)Ropinirole CR-RLS
Mean48.2 ± 14.7
Sex: Female, Male
Sex: Female, Male(Participants)Ropinirole CR-RLS
Female23
Male12
Region of Enrollment
Region of Enrollment(Number of participants)Ropinirole CR-RLS
Japan35
08

Study locations

11 sites
  • GSK Investigational Site
    Fukuoka, 802-0084, Japan
  • GSK Investigational Site
    Fukuoka, 810-0044, Japan
  • GSK Investigational Site
    Fukuoka, 830-0011, Japan
  • GSK Investigational Site
    Hiroshima, 733-0031, Japan
  • GSK Investigational Site
    Kanagawa, 210-0024, Japan
  • GSK Investigational Site
    Osaka, 550-0004, Japan
  • GSK Investigational Site
    Osaka, 589-0022, Japan
  • GSK Investigational Site
    Osaka, 599-8263, Japan
  • GSK Investigational Site
    Tochigi, 321-0293, Japan
  • GSK Investigational Site
    Tokyo, 151-0053, Japan
  • GSK Investigational Site
    Tokyo, 187-0041, Japan
09

References and documents

Publications

  • GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary with a conclusion.

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2007, a primary completion of Feb 2008 and a completion of Feb 2008. It does not say whether these dates are actual or estimated.

Results were first posted in Jul 2009, 1 year 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2007
First posted
Sep 17, 2007
Start
Aug 23, 2007
Primary completionActual
Feb 1, 2008
CompletionActual
Feb 1, 2008
Results first posted
Jul 24, 2009
Last update
Sep 26, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00530790
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 17, 2007
Start date
Aug 23, 2007
Primary completion
Feb 1, 2008
Completion
Feb 1, 2008
Results posted
Jul 24, 2009
Last update
Sep 26, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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