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

NicOx1,020 enrolled

Overview

To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication of signs and symptoms of osteoarthritis

This is a 53 week study consisting in a 26 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen. The first 26 weeks will be followed by a naproxen-controlled treatment period up to 52 weeks and a 1-week post-treatment safety follow-up.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,020

Conditions

Osteoarthritis

Interventions

Naproxcinod 375 mg bidDRUG

Naproxcinod 375 mg bid

Naproxcinod 750 mg bidDRUG

Naproxcinod 750 mg bid

Naproxen 500 mg bidDRUG

Naproxen 500 mg bid

placebo

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Men and Woman (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 anti-coagulant * Clinical relevant abnormal ECG * A history of alcohol or drug abuse * Candidates for imminent joint replacement * Participation within 30 days prior to screening in another investigational study

Locations (73)

Outcomes

Primary Outcomes

To show that both doses of Naproxcinod (375 mg twice daily [bid] and 750 mg bid) were superior to placebo in relieving osteoarthritis (OA) signs and symptoms in subjects with OA of the knee at Week 13.

Time frame: 13 weeks

Secondary Outcomes

To assess the efficacy of naproxcinod compared to naproxen 500 mg bid in relieving OA signs and symptoms in subjects with OA of the knee

Time frame: 52 weeks

To evaluate the effect on blood pressure (BP) of both doses of naproxcinod, placebo, and naproxen 500 mg bid, as measured by the office BP monitoring in a population of OA subjects

Time frame: 52 weeks

To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach

Time frame: 52 weeks

To assess if there were any radiological changes at Week 52 in naproxcinod compared with naproxen subjects (target joint radiographs were taken at Screening and after 52 weeks of treatment, or if early termination occurred after Week 26)

Time frame: 52 weeks

To compare the general safety and tolerability of both doses of naproxcinod versus naproxen 500 mg bid up to 52 weeks and with one Week post treatment follow up (Week 53)

Time frame: 53 weeks

Data from ClinicalTrials.gov

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Chandler, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Encino, California, United States

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Foothill Ranch, California, United States

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Orange, California, United States

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Rancho Mirage, California, United States

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Riverside, California, United States

...and 63 more locations