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NCT00664560 · 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 of Osteoarthritis, sponsored by POZEN.
- Completed
- Registry status
- Phase 3
- Development phase
- 614
- Enrollment target
- 1
- Study location
NCT00664560: Completed Phase 3 study of Osteoarthritis, sponsored by POZEN.
NCT00664560 is a Phase 3 study of Osteoarthritis that has completed, run by POZEN. The registered enrollment target is 614 participants, below the 813-participant average among 135 other Osteoarthritis trials with a reported enrollment target (24% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00664560, a Phase 3 study of Osteoarthritis, has completed, sponsored by POZEN.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 614 participants
- Enrollment target
- 1
- Study location
Study Summary
We will evaluate the efficacy of PN400 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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG PN 400 (VIMOVO)
- DRUG celebrex
- DRUG Rescue Antacid
Study Locations (1)
North Carolina
- POZEN - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 614 participants |
| Start Date | 2008-04 |
| Est. Completion | 2009-01 |
| Phase | Phase 3 |
What the finished NCT00664560 record still lists
NCT00664560 is an interventional study that assigns participants to a tested intervention. The registered 614 participants enrollment target is mid-sized for trials with a published cap, below the 813-participant average among 135 other Osteoarthritis trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Osteoarthritis appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00664560 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00664560 about?
NCT00664560 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 PN400 and an active comparator in patients that have Osteoarthritis of the knee.
What is the current status of trial NCT00664560?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 614 participants. The study started on 2008-04. Estimated completion is 2009-01.
What conditions does trial NCT00664560 study?
This clinical trial studies the following conditions: Osteoarthritis.
What interventions are being tested in trial NCT00664560?
The interventions under investigation include: Placebo (DRUG), PN 400 (VIMOVO) (DRUG), celebrex (DRUG), Rescue Antacid (DRUG).
Who is sponsoring clinical trial NCT00664560?
This trial is sponsored by POZEN, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00664560 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Osteoarthritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00664560's enrollment target sits among peer trials
614 25th of 135 higher than 111 of 135 other Osteoarthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis 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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Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial I
COMPLETED · Phase 3
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