CClinicalTrials.gg
Sign In
CompletedNCT01811238TALENTUpdated May 12, 2016Results posted

An Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Spinal Disorders

A Phase 4 interventional study of Oxycodone/naloxone in Spinal Disorders, sponsored by Mundipharma Korea Ltd. Completed. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-05-12.

Sponsored by Mundipharma Korea Ltd · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
240
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
All
01

Study summary

Study Objectives:

  1. Primary objective

    • To assess the pain reduction after 8 weeks treatment from baseline (week 0)

  2. Secondary objectives

    • To assess the pain reduction after 4 weeks treatment from baseline (week 0)
    • To assess the EQ-5D
    • To assess physician's overall satisfaction
    • To assess subject's overall satisfaction
    • To assess safety
Read the detailed description

Study Design (Methodology):

This will be a multicenter, phase IV, interventional study to assess the efficacy and safety of TARGIN(R)(Oxycodone/Naloxone) in Korean patients who are dissatisfied with their current analgesic medication (WHO step II analgesics).

Upon providing written informed consent, subject will be screened in the study and assessment will be performed at that time such as safety laboratory assessments, physical examination, vital sign, medical history taking, 24 hours pain intensity score, EQ-5D, physician's overall satisfaction and subject's overall satisfaction. If patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient will receive treatment with TARGIN(R). Re-screening, study drug dose interruption is not allowed. The duration of study drug dose interruption is defined as for 1 week.

Treatment with TARGIN(R) will be started at 5/2.5mg b.i.d.,and proper titration (up titration) will be allowed at each visit or at unscheduled visit according to the investigator's decision. On-site visit or phone call will be allowed for visit 2(wk 1).The up titration will be considered by investigator's judgement as followings; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average numerical rating scale

, if the numerical rating scale was changed to worsen since the previous visit, (3) Investigator's judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication). Pain assessment by investigator at each visit will be used for analysis and criteria for uptitration. Daily pain diary will be used for only criteria for uptitration.

Safety laboratories will be obtained at baseline (visit 1) and study end (visit 4) in a local laboratory. The laboratory values within 4 weeks prior to baseline (visit 1) will be allowed to use at study visit 1.

The rescue medication is the IRcodon(R).

Patients will be withdrawn from the study if the following circumstance require study drug discontinuation:

  • Failure of pain control (Failure of pain control will be decided by investigators judgement, e.g. there is poor pain control or lack of efficacy despite 2\~3 times of titration.)
  • Adjustment of the other analgesics due to Adverse event except TARGIN(R) or IRcodon(R)
  • Adjustment of the other major pain management modality (e.g. surgery, non-surgical interventional therapy, etc.)
  • Withdrawal of informed consent
  • Pregnancy
  • Any other significant risk to the patient's safety in the clinical judgement of the investigator
02

Conditions studied

  • Spinal Disorders

Browse trials for

Keywords

  • spinal disorders
03

In context

Spinal Diseases

267 studies on the registry are indexed under Spinal Diseases; 54 are open to participants now.

This study's enrollment of 240 is above the median of 52 across 166 interventional studies indexed under Spinal Diseases.

Browse Spinal Diseases studies →

Lead sponsor

Mundipharma Korea Ltd is the lead sponsor of 16 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female ≥ 20 and \<80 years of age
  • Patients who have spinal disorders related pain for over 90days
  • Patients who have moderate to severe pain intensity which is not controlled with weak opioids or NSAIDs: NRS ≥ 4
  • Naïve patients for Oxycodone/Naloxone
  • Naïve patients for strong opioid
  • Patients who signed a written informed consent form

Exclusion criteria

Exclusion Criteria:

  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
  • Patients with known hypersensitivity to Oxycodone/Naloxone or to any of the excipients
  • Patients with severe respiratory depression with hypoxia and/or hypercapnoea
  • Patients with severe chronic obstructive pulmonary disease
  • Patients with cor pulmonale
  • Patients with severe bronchial asthma
  • Patients who have been diagnosed or is suspected of having paralytic or obstructive ileus.Patients with moderate to severe hepatic impairment
  • Targin(R) product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take
  • Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (>2.5 times the upper limit of normal, it is allowed >5 times the upper limit of normal in case of transition in liver) or an abnormal total bilirubin and/or creatinine level (s)(greater than 1.5 times the upper limit of normal), gamma glutamyl transpeptidase (GGT or GGTP) ≥ 3 times the upper limit of normal
  • Patients with uncontrolled seizures
  • Requiring interventional treatment for pain such as neurodestructive procedure or regional infusion
  • Patients with increased intracranial pressure
  • In the investigator's opinion, subjects who are receiving hypnotics or central nervous system (CNS) depressants that may pose a risk of additional CNS depression with opioid study medication
  • Patients with myxodema, not adequately treated hypothyroidism or Addisons disease
  • Patients receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine)
  • Clinically significant impairment of cardiovascular, respiratory and renal function
  • Major surgery within 1 month prior to screening or planned surgery
  • Mainly pain originated other than spinal disorders disease
  • Non-malignant patients or cancer patients who are receiving any oncology treatment that could affect the measure of pain control
  • Patients with uncontrolled constipation regardless of laxative use and/or laxative type
  • With a disability that may prevent the patient from completing all study requirements and in particular, interfere with 24hrs pain intensity score
  • Patients known to have, or suspected of having a history of drug abuse
  • Patients with history of opioid or drug dependence
  • Any situation where opioids are contraindicated
  • Patient who needs acute dose titration or whose pain intensity fluctuate significantly in a short period according to investigator's judgment
  • Having used other investigational drugs at the time of enrollment

No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.

05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    Oxycodone/Naloxone

    Single-arm study

    Drug: Oxycodone/naloxone

Interventions

  • DrugOxycodone/naloxone

    Targin 5mg, 10mg, 20mg up to 40mg b.i.d

    Also known as: Targin

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Pain Intensity of Patient With Spinal Disorder as Measured by NRS.

    NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week 8/ET minus mean score at Baseline.

    Time frame: Baseline, 8 week

Secondary outcomes

  1. The Change in Quality of Life (EQ-5D) at Week 8 of Treatment With the Study Drug From Baseline

    EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2) \*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents) EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by "1" means that the healthy condition and high quality of life.

    Time frame: Baseline, 8 week

  2. Clinical Global Impression of Change(CGIC)

    The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF. Very much improved much improved minimally improved no change minimally worse much worse very much worse

    Time frame: Baseline, 8 week

  3. Change of Pain Intensity in Patient With Spinal Disorder at Week 4 of Treatment With the Study Drug From Baseline

    NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week 4/ET minus mean score at Baseline.

    Time frame: Baseline, 4 week

  4. Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)

    The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score = 100) and 'Worst imaginable health state' (score = 0). Higher points were positive results and positive points of difference gap means improvement results.

    Time frame: Baseline, 8 weeks

  5. Patient Global Impression of Change(PGIC)

    Number of participants with categorical change in overall satisfaction. PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).

    Time frame: Baseline, 8week

07

Results

Posted May 12, 2016

Participant flow

The 10 general hospitals were recruited patients from 26 Sep. 2012 to 02 Aug. 2013.

Participant flow — Overall Study
MilestoneOxycodone/Naloxone
Started240
Safety set220
Itt set209
Pp set120
Completed159
Not completed81
Withdrew: Withdrawal by subject42
Withdrew: Adverse event25
Withdrew: Protocol violation4
Withdrew: Lack of efficacy4
Withdrew: Subject refused study medication6

Outcome measures

PrimaryChange From Baseline in Pain Intensity of Patient With Spinal Disorder as Measured by NRS.

NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week 8/ET minus mean score at Baseline.

Time frame:
Baseline, 8 week
Reported as:
Mean · scores on a scale
Change From Baseline in Pain Intensity of Patient With Spinal Disorder as Measured by NRS.
scores on a scaleOxycodone/Naloxone
Change From Baseline in Pain Intensity of Patient With Spinal Disorder as Measured by NRS.-1.69 ± 2.18
Statistical analysis
  • Oxycodone/Naloxone · t-test, 2 sided · p = <0.05 · Mean difference (final values): -1.69The primary endpoint will be the actual reduction rate of pain intensity (0 -10) score at 8 weeks. It will be analyzed by using paired t-test.
SecondaryThe Change in Quality of Life (EQ-5D) at Week 8 of Treatment With the Study Drug From Baseline

EQ-5D to measure of health related quality of life should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2) \*EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents) EQ-5D total score could be 0.919 in maximum and -0.594 in minimum if case all index indicates the level 3. So, if EQ-5D total score closed by "1" means that the healthy condition and high quality of life.

Time frame:
Baseline, 8 week
Reported as:
Mean · scores on a scale
The Change in Quality of Life (EQ-5D) at Week 8 of Treatment With the Study Drug From Baseline
scores on a scaleOxycodone/Naloxone
The Change in Quality of Life (EQ-5D) at Week 8 of Treatment With the Study Drug From Baseline0.15 ± 0.37
Statistical analysis
  • Oxycodone/Naloxone · t-test, 2 sided · p = <0.05 · Mean difference (final values): 0.15 · 95% CI 0 to 1.12The change(difference) in EQ-5D score at Week 8 from baseline was analyzed by using paired t-test.
SecondaryClinical Global Impression of Change(CGIC)

The number of patients who choose the best opinion of overall satisfaction among Clinical Global Impression of Change Scale(CGIC) among 7 point scale. Missing data was imputed by LOCF. Very much improved much improved minimally improved no change minimally worse much worse very much worse

Time frame:
Baseline, 8 week
Reported as:
Number · participants
Clinical Global Impression of Change(CGIC)
participantsOxycodone/Naloxone
Very much improved20
Much improved49
Minimally improved70
No change57
Minimally worse6
much worse5
Very much worse2
SecondaryChange of Pain Intensity in Patient With Spinal Disorder at Week 4 of Treatment With the Study Drug From Baseline

NRS-Pain scale assessed the severity of a subject's pain of mean pain over the past 24 hours prior to the visit on a scale of 0 (No pain) and 10 (Worst possible pain). Change = mean score at Week 4/ET minus mean score at Baseline.

Time frame:
Baseline, 4 week
Reported as:
Mean · units on a scale
Change of Pain Intensity in Patient With Spinal Disorder at Week 4 of Treatment With the Study Drug From Baseline
units on a scaleOxycodone/Naloxone
Change of Pain Intensity in Patient With Spinal Disorder at Week 4 of Treatment With the Study Drug From Baseline-1.36 ± 2.04
SecondaryChange From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)

The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' (score = 100) and 'Worst imaginable health state' (score = 0). Higher points were positive results and positive points of difference gap means improvement results.

Time frame:
Baseline, 8 weeks
Reported as:
Mean · scores on a scale
Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)
scores on a scaleOxycodone/Naloxone
Change From Baseline in Health-related Quality of Life Assessed by EuroQol Visual Analog Scale (EQ-5D VAS)10.57 ± 22.11
SecondaryPatient Global Impression of Change(PGIC)

Number of participants with categorical change in overall satisfaction. PGIC: a participant-rated instrument assessing change in participant's overall satisfaction from baseline, on a scale ranging from 1 (very much improved) to 7 (very much worse).

Time frame:
Baseline, 8week
Reported as:
Number · participants
Patient Global Impression of Change(PGIC)
participantsOxycodone/Naloxone
Very much improved16
Much improved49
Minimally improved69
No change60
Minimally worse6
Much worse6
Very much worse3

Adverse events

Collected over Follow up 8 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Oxycodone/Naloxone—3/220 (1.4%)77/220 (35%)
Most frequent serious events
Most frequent serious events
EventOxycodone/Naloxone
Femur fractureMusculoskeletal and connective tissue disorders1/220
osteoarthritisMusculoskeletal and connective tissue disorders1/220
Renal cancerRenal and urinary disorders1/220
Most frequent other events
Showing 10 of 32
Most frequent other events
EventOxycodone/Naloxone
NauseaGastrointestinal disorders21/220
DizzinessNervous system disorders14/220
constipationGastrointestinal disorders12/220
PruritusSkin and subcutaneous tissue disorders11/220
Decreased appetiteMetabolism and nutrition disorders7/220
DyspepsiaGastrointestinal disorders6/220
SomnolenceNervous system disorders6/220
VomitingGastrointestinal disorders5/220
Abdominal painGastrointestinal disorders5/220
HeadacheNervous system disorders4/220

Baseline characteristics

Total 240 patients were enrolled. However, 20 patients were excluded due to no administeration of investigational drug during the study. The 220 is Safety set population included all subjects who had at least one dose of the study drug.

Age, Continuous
Age, Continuous(years)Oxycodone/Naloxone
Mean62.25 ± 10.42
Age, Categorical
Age, Categorical(Participants)Oxycodone/Naloxone
<=18 years0
Between 18 and 65 years86
>=65 years134
Sex: Female, Male
Sex: Female, Male(Participants)Oxycodone/Naloxone
Female136
Male84
Region of Enrollment
Region of Enrollment(participants)Oxycodone/Naloxone
Korea, Republic of220
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Hwang CJ, Chung SS, Lee KY, Lee JH, Moon SH, Kim JH, Cho KJ, Ahn JS, Kim DS, Park YS, Park HJ. Analgesic Efficacy and Safety of Prolonged-Release Oxycodone/Naloxone in Korean Patients with Chronic Pain from Spinal Disorders. Clin Orthop Surg. 2018 Mar;10(1):33-40. doi: 10.4055/cios.2018.10.1.33. Epub 2018 Feb 27. PubMed 29564045 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01811238
Lead sponsor
Mundipharma Korea Ltd
Responsible party
Sponsor
First posted
Mar 14, 2013
Start date
Sep 2012
Primary completion
Apr 2013
Completion
Jul 2013
Results posted
May 12, 2016
Last update
May 12, 2016

Study contacts

Sung Soo Shung
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Spinal Diseases→

Other studies from this sponsor

Mundipharma Korea Ltd

Start the discussion