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

NicOx918 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

918

Conditions

Osteoarthritis

Interventions

PlaceboDRUG

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 mgDRUG

NaproxenDRUG

Naproxcinod 750 mg

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The primary objective of this study is to show that naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the knee at 13 weeks and to collect long term safety data

Time frame: 13 weeks / long term

Data from ClinicalTrials.gov

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