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

NicOx

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: Naproxcinod 750 mg; Drug: Placebo; Drug: Naproxen; Drug: Naproxcinod 375 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00542555

HCT3012-X-301/301E

Details and patient eligibility

About

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

Full description

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.

Enrollment: 918 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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918 participants in 4 patient groups, including a placebo group

Placebo bid

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Naproxcinod 375 mg bid

Experimental group

Treatment:

Drug: Naproxcinod 375 mg

Naproxen 500 mg bid

Active Comparator group

Treatment:

Drug: Naproxen

Naproxcinod 750 mg bid

Experimental group

Treatment:

Drug: Naproxcinod 750 mg