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Efficacy Study of PN400 (VIMOVO) Twice Daily and Celebrex Once Daily in Patients With Osteoarthritis

NCT00665431 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 610

Last updated 2011-12-06

Study results available
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Summary

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

Conditions

Interventions

DRUG

PN 400 (VIMOVO)

500 mg naproxen/20 mg esomeprazole bid

DRUG

celebrex

200 mg celecoxib qd

OTHER

Placebo

sugar pill bid

DRUG

Rescue Antacid

Antacid Tablets

Sponsors & Collaborators

  • POZEN

    lead INDUSTRY

Principal Investigators

  • Everardus Orlemans, PhD · POZEN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-12-31
Completion
2009-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00665431 on ClinicalTrials.gov