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NCT00665431 · ClinicalTrials.gov registry record · Phase 3
Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis
A Phase 3 study, sponsored by POZEN.
- Completed
- Registry status
- Phase 3
- Development phase
- 610
- Enrollment target
NCT00665431: Completed Phase 3 study, sponsored by POZEN.
NCT00665431 is a Phase 3 study that has completed, run by POZEN. The registered enrollment target is 610 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00665431, a Phase 3 study, has completed, sponsored by POZEN.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 610 participants
- Enrollment target
Study Summary
We will evaluate the efficacy of PN 400 and an active comparator in patients that have Osteoarthritis of the knee.
Primary Outcome
Western Ontario and McMaster Universities (WOMAC) pain questionnaire has 5 questions on pain all use visual analog scale (VAS) of 100 mm, with 0 mm being "no pain" and 100 mm being "extreme pain". The outcome measures a change in WOMAC pain at 12 weeks from baseline (in mm). WOMAC is a self-administered, patient-reported health status questionnaire designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. It consists of 24 question
Interventions
- OTHER Placebo
- DRUG PN 400 (VIMOVO)
- DRUG celebrex
- DRUG Rescue Antacid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 610 participants |
| Start Date | 2008-04 |
| Est. Completion | 2009-01 |
| Phase | Phase 3 |
What the finished NCT00665431 record still lists
NCT00665431 is an interventional study that assigns participants to a tested intervention. The registered 610 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00665431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00665431 about?
NCT00665431 is a clinical study titled "Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis". We will evaluate the efficacy of PN 400 and an active comparator in patients that have Osteoarthritis of the knee.
What is the current status of trial NCT00665431?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 610 participants. The study started on 2008-04. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00665431?
The interventions under investigation include: Placebo (OTHER), PN 400 (VIMOVO) (DRUG), celebrex (DRUG), Rescue Antacid (DRUG).
Who is sponsoring clinical trial NCT00665431?
This trial is sponsored by POZEN, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00665431's enrollment target sits among peer trials
610 601st of 2000 higher than 1,399 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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