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 375 mg bid; Drug: Naproxcinod 750 mg bid; Drug: Naproxen 500 mg bid; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00504127

HCT 3012-X-302

Details and patient eligibility

About

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

Full description

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.

Enrollment: 1,020 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,020 participants in 4 patient groups, including a placebo group

naproxcinod 375 mg bid

Experimental group

Treatment:

Drug: Naproxcinod 375 mg bid

naproxcinod 750 mg bid

Experimental group

Treatment:

Drug: Naproxcinod 750 mg bid

naproxen 500 mg bid

Active Comparator group

Treatment:

Drug: Naproxen 500 mg bid

placebo

Placebo Comparator group

Treatment:

Drug: placebo