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

NicOx

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis, Hip; Osteoarthritis

Treatments: Drug: Placebo; Drug: Naproxen; Drug: Naproxcinod

Study type: Interventional

Funder types: Industry

Identifiers

NCT00541489

HCT3012-X-303

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 randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen.

Enrollment: 800 estimated 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 hip
• 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
• Clinically relevant abnormal ECG
• A history of alcohol or drug abuse
• Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
• Current medical disease, including arthritic, that could confound or interfere with the evaluation of efficacy
• 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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800 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Drug: Placebo

2

Active Comparator group

Description:

Naproxen 500 mg

Treatment:

Drug: Naproxen

3

Experimental group

Description:

Naproxcinod 750 mg

Treatment:

Drug: Naproxcinod