MedTrace Logo

Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee

NCT00542555 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 918

Last updated 2011-06-17

No results posted yet for this study

Summary

To study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of Osteoarthritis.

Conditions

Interventions

DRUG

Placebo

At 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study.

DRUG

Naproxcinod 375 mg

DRUG

Naproxen

DRUG

Naproxcinod 750 mg

Sponsors & Collaborators

  • NicOx

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Completion
2007-09-30

More Related Trials

Entities

Drugs
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 NCT00542555 on ClinicalTrials.gov