CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 610 enrolled
Drug / intervention
PN 400 (VIMOVO) +3 moredrug
Likely dose
PN 400 (VIMOVO) 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00665431
NCT00665431Phase 3Completed

Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Center Study Evaluating the Efficacy of PN400 (VIMOVO) Twice Daily (Bid) and Celecoxib Once Daily (qd) in Patients With Osteoarthritis of the Knee

POZEN·interventional·Posted Apr 23, 2008·Updated Dec 6, 2011

In Brief

A Phase 3 clinical trial evaluating PN 400 (VIMOVO), celebrex, and 2 other interventions for Osteoarthritis. Completed, enrolled 610 participants across 1 site.

Detailed Summary

We will evaluate the efficacy of PN 400 and an active comparator in patients that have Osteoarthritis of the knee.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 23, 2008
Enrollment StartApr 1, 2008
Primary CompletionDec 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.2 years ago

Interventions

PN 400 (VIMOVO)drug

500 mg naproxen/20 mg esomeprazole bid

celebrexdrug

200 mg celecoxib qd

Placeboother

sugar pill bid

Rescue Antaciddrug

Antacid Tablets