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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

918 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-09-30

Brief Summary

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

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Detailed Description

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This is a 13-week double-blind study followed by a 52-week, open-label, roll-over on active treatment study. These are randomized, parallel group, multicenter studies comparing efficacy and safety of naproxcinod, placebo and naproxen.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo bid

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Naproxcinod 375 mg bid

Group Type EXPERIMENTAL

Naproxcinod 375 mg

Intervention Type DRUG

Naproxen 500 mg bid

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

Naproxcinod 750 mg bid

Group Type EXPERIMENTAL

Naproxcinod 750 mg

Intervention Type DRUG

Interventions

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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.

Intervention Type DRUG

Naproxcinod 375 mg

Intervention Type DRUG

Naproxen

Intervention Type DRUG

Naproxcinod 750 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women (40 or older) with a diagnosis of primary OA of the knee
* Must be a current chronic user of NSAIDS or acetaminophen
* Must discontinue all analgesic therapy at screening

Exclusion Criteria

* Uncontrolled hypertension or diabetes
* Hepatic or renal impairment
* Current or expected use of anticoagulant
* A history of alcohol or drug abuse
* Candidates for imminent joint replacement
* Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
* Current medical disease that could confound or interfere with the evaluation of efficacy
* Participation within 30 days prior to screening in another investigational study

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No