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CompletedNCT00103402Updated Jun 12, 2020Results posted

Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome

A Phase 3 interventional study of Alfuzosin and Placebo in Prostatitis, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Completed at 10 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-12.

Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
272
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Alfuzosin is a once daily (10 mg capsule), FDA approved medication for an indication in benign prostatic hyperplasia (BPH). The effectiveness of alfuzosin in improving lower urinary tract symptoms in patients with BPH has been documented in a number of placebo-controlled studies. A number of small studies have also suggested that alfuzosin ameliorates CP/CPPS symptoms through a similar alpha-blockade mechanism. This study will enable further testing of this hypothesis

Read the detailed description

The two primary objectives of this study are:

  • To compare 12 weeks of treatment with alfuzosin versus placebo in newly-diagnosed, alpha-blocker naive CP/CPPS participants with respect to the primary endpoint in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).
  • To evaluate the safety and tolerability of 12 weeks of alfuzosin in newly-diagnosed, alpha-blocker naïve CP/CPPS participants.

The proportion of "responders" in each treatment arm will be compared to evaluate the overall safety and efficacy of alfuzosin as compared to placebo. Approximately 270 eligible patients, 135 per treatment arm, will be randomized and followed for a period of twelve (12) weeks after randomization.

There will be four research-clinic visits during which data for the primary and secondary outcome measures will be collected: visit 1 involves screening, visit 2 involves collection of baseline data and randomization, visit 3 is the 6-week evaluation, and visit 4 is the 12-week evaluation of the primary end point.

02

Conditions studied

  • Prostatitis

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Keywords

  • Prostatitis
  • Non-bacterial Prostatitis
  • Prostatodynia
  • Alfuzosin
  • Alpha-adrenergic blocker
03

In context

Prostatitis

88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.

This study's enrollment of 272 is above the median of 60 across 73 interventional studies indexed under Prostatitis.

Browse Prostatitis studies →

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 538 studies on the registry; 55 are open to participants now.

Of its 80 completed or terminated interventional studies of FDA-regulated products, 51 (64%) have results posted.

Browse National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) studies →

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
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

  • Participant has signed and dated the appropriate document.
  • Participant is male.
  • Participant is at least 18 years of age.
  • Participant has had symptoms of discomfort or pain in the pelvic region for at least a six-week interval at the time of presentation.
  • Symptoms bothersome enough to prompt a physician visit have been present for two years or less.

Exclusion criteria

Exclusion Criteria:

  • Participant has evidence of facultative Gram negative or enterococcus with a value of greater than or equal to 1000 colony forming units (CFU) /ml in mid-stream urine (VB2).
  • Participant has previously received alfuzosin (Uroxatral®), tamsulosin hydrochloride (Flomax®), doxazosin mesylate (Cardura®), terazosin hydrochloride (HCL) (Hytrin®), or other alpha-adrenergic receptor blockers for symptoms of CP/CPPS or within the past two years for any other reason.
  • Participant has a history of prostate, penile, testicular, bladder, or urethral cancer or has undergone pelvic radiation, systemic chemotherapy, or intravesical chemotherapy.
  • Participant has a history of moderate or severe hepatic impairment, severe renal sufficiency, severe or unstable cardiovascular (i.e. prolonged ), respiratory, hematological, endocrinological, neurological or other somatic disorders.
  • Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture, or neurological disease or disorder affecting the bladder.
  • Participant has uninvestigated, significant hematuria.
  • Participant has undergone transurethral prostatectomy (TURP), transurethral incision of the prostate (TUIP), transurethral Incision or Resection of the Bladder Neck (TUIBN), transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment such as cryotherapy or thermal therapy.
  • Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
  • Participant is currently taking exclusionary medications such as potent inhibitors (i.e. ketoconazole, itraconazole, or ritonavir) or erythromycin.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

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05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
272 participants (actual)

Study arms

  • Experimental
    Alfuzosin

    10 mg of alfuzosin once daily for 12 weeks

    Drug: Alfuzosin

  • Placebo comparator
    Placebo

    10 mg of an identical-looking placebo once daily for 12 weeks

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks

    For the National Institutes of Health Chronic Prostatitis Symptom Index (NIHCPSI) total score, higher scores indicate more severe symptoms and scores range from 0 to 43. The primary outcome was a decline of at least 4 from baseline to 12 weeks

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Global Response Assessment (GRA)

    The response rate for the global response assessment was based on marked or moderate improvement at 12 weeks using a 7 point scale (marked worsening, moderate worsening, no change, slight improvement, moderate improvement, marked improvement).

    Time frame: 12 weeks

  2. Change in Subscales of the NIH-CPSI

    For the National Institutes of Health Chronic Prostatitis Symptom Index (NIHCPSI), higher scores indicate more severe symptoms (for the quality-of-life score, higher scores indicate a more negative effect). Score ranges are as follows: total score, 0 to 43; pain score, 0 to 21; urinary score, 0 to 10, quality-of-life score, 0 to 12; and average pain and urgency scores, 0 to 10.

    Time frame: Baseline and12 weeks

  3. Change in Subscales of the McGill Pain Questionnaire

    For the McGill Pain Questionnaire, higher scores indicate greater pain. Score ranges are as follows: total score, 0 to 45; sensory score, 0 to 33; affective score, 0 to 12.

    Time frame: Baseline and 12 weeks

  4. Change in Medical Outcomes Study Short Form 12

    For the Medical Outcomes Study Short Form Health Survey 12 (SF-12), higher scores indicate better quality of life. Score range for both the physical and mental component summaries is 0 to 100.

    Time frame: Baseline and 12 weeks

  5. Change in Hospital Anxiety and Depression Scale

    For the Hospital Anxiety and Depression Scale, higher scores indicate greater anxiety and depression; range, 0 to 42.

    Time frame: Baseline and 12 weeks

  6. Change in International Index of Erectile Dysfunction (IIEF)

    For the International Index of Erectile Function, higher scores indicate better sexual function; range, 0 to 75.

    Time frame: Baseline and 12 weeks

  7. Change in Male Sexual Health Questionnaire

    For the Male Sexual Health Questionnaire, higher scores indicate better function with respect to erection and ejaculation and greater satisfaction with sexual life; range, 0 to 40.

    Time frame: Baseline and 12 weeks

07

Results

Posted Jun 12, 2020

Participant flow

Participant flow — Overall Study
MilestoneAlfuzosinPlacebo
Started138134
Completed116117
Not completed2217
Withdrew: Adverse event34
Withdrew: Lost to follow-up87
Withdrew: Dissatisfied/no longer interested66
Withdrew: Personal constraints/other50

Outcome measures

PrimaryNumber of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks

For the National Institutes of Health Chronic Prostatitis Symptom Index (NIHCPSI) total score, higher scores indicate more severe symptoms and scores range from 0 to 43. The primary outcome was a decline of at least 4 from baseline to 12 weeks

Time frame:
Baseline and 12 weeks
Reported as:
Count of participants · Participants
Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks
ParticipantsAlfuzosinPlacebo
Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks6866
Statistical analysis
  • Alfuzosin vs Placebo · Mantel Haenszel · p = 0.99 · Risk difference (rd): 0.1 · 95% CI -11.2 to 11.0The exact conditional test version of the Mantel-Haenszel test was used to control for clustering by clinical center.
SecondaryGlobal Response Assessment (GRA)

The response rate for the global response assessment was based on marked or moderate improvement at 12 weeks using a 7 point scale (marked worsening, moderate worsening, no change, slight improvement, moderate improvement, marked improvement).

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Global Response Assessment (GRA)
ParticipantsAlfuzosinPlacebo
Marked improvement2316
Moderate improvement2529
Slight improvement2632
No change3636
Slight worsening65
Moderate worsening24
Marked worsening11
Statistical analysis
  • Alfuzosin vs Placebo · Mantel Haenszel · p = 0.90 · Risk difference (rd): 1.8 · 95% CI -9.0 to 2.5
SecondaryChange in Subscales of the NIH-CPSI

For the National Institutes of Health Chronic Prostatitis Symptom Index (NIHCPSI), higher scores indicate more severe symptoms (for the quality-of-life score, higher scores indicate a more negative effect). Score ranges are as follows: total score, 0 to 43; pain score, 0 to 21; urinary score, 0 to 10, quality-of-life score, 0 to 12; and average pain and urgency scores, 0 to 10.

Time frame:
Baseline and12 weeks
Reported as:
Mean · units on a scale
Change in Subscales of the NIH-CPSI
units on a scaleAlfuzosinPlacebo
Total score-7.1 ± 9.0-6.5 ± 8.5
Pain score-3.3 ± 4.5-3.0 ± 4.4
Urinary score-1.2 ± 2.6-1.0 ± 2.6
Quality-of-life score-1.2 ± 1.5-1.2 ± 1.5
Statistical analysis
  • Alfuzosin vs Placebo · t-test, 2 sided · p = 0.70 · Mean difference (net): -0.5 · 95% CI -2.7 to 1.5
  • Alfuzosin vs Placebo · t-test, 2 sided · p = 0.64 · Mean difference (net): -0.3 · 95% CI -1.4 to 0.8
  • Alfuzosin vs Placebo · t-test, 2 sided · p = 0.62 · Mean difference (net): -0.2 · 95% CI -0.8 to 0.4
  • Alfuzosin vs Placebo · t-test, 2 sided · p = .99 · Mean difference (net): 0 · 95% CI -0.4 to 0.4
SecondaryChange in Subscales of the McGill Pain Questionnaire

For the McGill Pain Questionnaire, higher scores indicate greater pain. Score ranges are as follows: total score, 0 to 45; sensory score, 0 to 33; affective score, 0 to 12.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · units on a scale
Change in Subscales of the McGill Pain Questionnaire
units on a scaleAlfuzosinPlacebo
Total score-3.4 ± 6.4-3.1 ± 6.5
Sensory score-2.5 ± 5.0-2.3 ± 4.9
Affective score-1.0 ± 2.1-0.9 ± 2.3
Statistical analysis
  • Alfuzosin vs Placebo · t-test, 2 sided · p = 0.45 · Mean difference (net): -0.3 · 95% CI -1.8 to 1.2
  • Alfuzosin vs Placebo · t-test, 2 sided · p = 0.47 · Mean difference (net): -0.2 · 95% CI -1.4 to 1.0
  • Alfuzosin vs Placebo · t-test, 2 sided · p = 0.89 · Mean difference (net): -0.1 · 95% CI -0.6 to 0.4
SecondaryChange in Medical Outcomes Study Short Form 12

For the Medical Outcomes Study Short Form Health Survey 12 (SF-12), higher scores indicate better quality of life. Score range for both the physical and mental component summaries is 0 to 100.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · units on a scale
Change in Medical Outcomes Study Short Form 12
units on a scaleAlfuzosinPlacebo
Physical component3.0 ± 7.43.5 ± 8.1
Mental component4.0 ± 10.51.9 ± 10.6
Statistical analysis
  • Alfuzosin vs Placebo · t-test, 2 sided · p = 0.60 · Mean difference (net): -0.5 · 95% CI -2.3 to 1.3
  • Alfuzosin vs Placebo · t-test, 2 sided · p = 0.16 · Mean difference (net): 2.1 · 95% CI -0.4 to 4.6
SecondaryChange in Hospital Anxiety and Depression Scale

For the Hospital Anxiety and Depression Scale, higher scores indicate greater anxiety and depression; range, 0 to 42.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · units on a scale
Change in Hospital Anxiety and Depression Scale
units on a scaleAlfuzosinPlacebo
Change in Hospital Anxiety and Depression Scale-2.6 ± 5.7-1.5 ± 5.5
Statistical analysis
  • Alfuzosin vs Placebo · t-test, 2 sided · p = 0.08 · Mean difference (net): -1.1 · 95% CI -2.4 to 0.2
SecondaryChange in International Index of Erectile Dysfunction (IIEF)

For the International Index of Erectile Function, higher scores indicate better sexual function; range, 0 to 75.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · units on a scale
Change in International Index of Erectile Dysfunction (IIEF)
units on a scaleAlfuzosinPlacebo
Change in International Index of Erectile Dysfunction (IIEF)0.5 ± 12.7-0.2 ± 14.7
Statistical analysis
  • Alfuzosin vs Placebo · t-test, 2 sided · p = 0.94 · Risk difference (rd): 0.7 · 95% CI -2.6 to 4.0
SecondaryChange in Male Sexual Health Questionnaire

For the Male Sexual Health Questionnaire, higher scores indicate better function with respect to erection and ejaculation and greater satisfaction with sexual life; range, 0 to 40.

Time frame:
Baseline and 12 weeks
Reported as:
Mean · units on a scale
Change in Male Sexual Health Questionnaire
units on a scaleAlfuzosinPlacebo
Change in Male Sexual Health Questionnaire1.7 ± 4.50.6 ± 6.8
Statistical analysis
  • Alfuzosin vs Placebo · t-test, 2 sided · p = 0.06 · Mean difference (net): 1.1 · 95% CI -0.3 to 2.5

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Alfuzosin0/138 (0%)1/138 (0.7%)40/138 (29%)
Placebo0/134 (0%)2/134 (1.5%)46/134 (34.3%)
Most frequent serious events
Most frequent serious events
EventAlfuzosinPlacebo
Myocardial infarctionCardiac disorders0/1381/134
Traumatic head lacerationInvestigations0/1381/134
Spontaneous pneumothoraxRespiratory, thoracic and mediastinal disorders1/1380/134
Most frequent other events
Most frequent other events
EventAlfuzosinPlacebo
Pain in any body systemGeneral disorders15/13820/134
Gastrointestinal eventsGastrointestinal disorders10/13813/134
Neurologic eventsNervous system disorders11/1386/134
Constitutional eventsGeneral disorders4/1387/134

Baseline characteristics

Age, Continuous
Age, Continuous(years)AlfuzosinPlaceboTotal
Mean40.1 ± 11.440.1 ± 12.340.1 ± 11.8
Sex: Female, Male
Sex: Female, Male(Participants)AlfuzosinPlaceboTotal
Female000
Male138134272
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AlfuzosinPlaceboTotal
American Indian or Alaska Native000
Asian131427
Native Hawaiian or Other Pacific Islander000
Black or African American201636
White8897185
More than one race000
Unknown or Not Reported17724
NIH-CPSI
NIH-CPSI(units on a scale)AlfuzosinPlaceboTotal
Total score23.8 ± 6.325.1 ± 5.924.5 ± 6.1
Pain score11.1 ± 3.311.5 ± 3.411.3 ± 3.4
Urinary score4.5 ± 2.84.9 ± 2.94.7 ± 2.9
Quality of life score4.5 ± 1.14.7 ± 0.94.6 ± 1.0
Likert Pain and Urgency Scale
Likert Pain and Urgency Scale(units on the scale)AlfuzosinPlaceboTotal
Average pain score4.9 ± 2.05.0 ± 1.95.0 ± 2.0
Urgency score4.4 ± 2.64.7 ± 2.64.6 ± 2.6
McGill Pain Questionnaire
McGill Pain Questionnaire(units on a scale)AlfuzosinPlaceboTotal
Total score11.2 ± 8.611.6 ± 8.711.4 ± 8.7
Sensory score8.6 ± 5.98.9 ± 6.28.8 ± 6.1
Affective score2.6 ± 3.32.6 ± 3.22.6 ± 3.3
SF-12
SF-12(units on a scale)AlfuzosinPlaceboTotal
Physical component summary45.5 ± 9.645.6 ± 8.445.6 ± 9.0
Mental component summary44.0 ± 10.944.9 ± 10.244.5 ± 10.6
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale(units on a scale)AlfuzosinPlaceboTotal
Mean12.8 ± 7.612.8 ± 7.112.8 ± 7.4

2 further baseline measures are reported on the registry.

08

Study locations

10 sites
  • David Geffen School of Medicine at UCLA
    Los Angeles, California 90095, United States
  • Stanford University Medical Center
    Stanford, California 94305, United States
  • Northwestern U. Feinberg School of Medicine
    Chicago, Illinois 60611, United States
  • University of Maryland
    Baltimore, Maryland 21201, United States
  • Harvard Medical School- Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Temple University
    Philadelphia, Pennsylvania 19140, United States
  • University of Washington- Harborview Medical Center
    Seattle, Washington 98108, United States
  • Queen's University
    Kingston, Ontario K7L 3N6, Canada
09

References and documents

Publications

  • Alexander RB, Propert KJ, Schaeffer AJ, Landis JR, Nickel JC, O'Leary MP, Pontari MA, McNaughton-Collins M, Shoskes DA, Comiter CV, Datta NS, Fowler JE Jr, Nadler RB, Zeitlin SI, Knauss JS, Wang Y, Kusek JW, Nyberg LM Jr, Litwin MS; Chronic Prostatitis Collaborative Research Network. Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial. Ann Intern Med. 2004 Oct 19;141(8):581-9. doi: 10.7326/0003-4819-141-8-200410190-00005. PubMed 15492337 ↗
  • Litwin MS. A review of the development and validation of the National Institutes of Health Chronic Prostatitis Symptom Index. Urology. 2002 Dec;60(6 Suppl):14-8; discussion 18-9. doi: 10.1016/s0090-4295(02)02296-3. PubMed 12521581 ↗
  • Schaeffer AJ; National Institute of Diabetes and Digestive and Kidney Diseases of the US National Institutes of Health. NIDDK-sponsored chronic prostatitis collaborative research network (CPCRN) 5-year data and treatment guidelines for bacterial prostatitis. Int J Antimicrob Agents. 2004 Sep;24 Suppl 1:S49-52. doi: 10.1016/j.ijantimicag.2004.02.009. PubMed 15364307 ↗
  • Schaeffer AJ, Landis JR, Knauss JS, Propert KJ, Alexander RB, Litwin MS, Nickel JC, O'Leary MP, Nadler RB, Pontari MA, Shoskes DA, Zeitlin SI, Fowler JE Jr, Mazurick CA, Kishel L, Kusek JW, Nyberg LM; Chronic Prostatitis Collaborative Research Network Group. Demographic and clinical characteristics of men with chronic prostatitis: the national institutes of health chronic prostatitis cohort study. J Urol. 2002 Aug;168(2):593-8. PubMed 12131316 ↗
  • Propert KJ, Alexander RB, Nickel JC, Kusek JW, Litwin MS, Landis JR, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Design of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome. Urology. 2002 Jun;59(6):870-6. doi: 10.1016/s0090-4295(02)01601-1. PubMed 12031372 ↗
  • Schaeffer AJ, Datta NS, Fowler JE Jr, Krieger JN, Litwin MS, Nadler RB, Nickel JC, Pontari MA, Shoskes DA, Zeitlin SI, Hart C; Chronic Prostatitis Collaborative Research Network. Overview summary statement. Diagnosis and management of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Urology. 2002 Dec;60(6 Suppl):1-4. doi: 10.1016/s0090-4295(02)01979-9. PubMed 12521576 ↗
  • Nickel JC, Krieger JN, McNaughton-Collins M, Anderson RU, Pontari M, Shoskes DA, Litwin MS, Alexander RB, White PC, Berger R, Nadler R, O'Leary M, Liong ML, Zeitlin S, Chuai S, Landis JR, Kusek JW, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Alfuzosin and symptoms of chronic prostatitis-chronic pelvic pain syndrome. N Engl J Med. 2008 Dec 18;359(25):2663-73. doi: 10.1056/NEJMoa0803240. PubMed 19092152 ↗

Individual participant data

Plan to share: Yes — Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/cpcrn2-rct1/?query=CPCRN

Data sharing details ↗ · repository.niddk.nih.gov

10

Timeline

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

The record gives a start of Feb 2005, a primary completion of Jan 2008 and a completion of Jan 2008. It does not say whether these dates are actual or estimated.

Results were first posted in Jun 2020, 12 years 5 months after primary completion.

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

Registered
Feb 7, 2005
First posted
Feb 8, 2005
Start
Feb 2005
Primary completionActual
Jan 2008
CompletionActual
Jan 2008
Results first posted
Jun 12, 2020
Last update
Jun 12, 2020
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 Jun 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00103402
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
University of Pennsylvania
Responsible party
Sponsor
First posted
Feb 8, 2005
Start date
Feb 2005
Primary completion
Jan 2008
Completion
Jan 2008
Results posted
Jun 12, 2020
Last update
Jun 12, 2020

Study contacts

Leroy Nyberg, MD PhD
study director · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
John Kusek, PhD
study director · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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