A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 study to Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) Pain of the Knee

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Noven Pharmaceuticals, Inc.
• Treatments: Diclofenac

Criteria

Inclusion Criteria:

• Male or female aged 40 to 85 years with a clinical diagnosis of OA of the target knee according to the American College of Rheumatology criteria.

• Has an X-ray of the target knee, taken no more than 1 year before Baseline, showing evidence of OA.

• Has pain of OA in the designated/target study knee.

Exclusion Criteria:

• Body mass index (BMI) > 40.

• Any subject who did not follow the restriction of prohibited therapies during Washout period.

• Arthritis of the target knee that is not caused by OA but caused by diseases such as rheumatoid arthritis, gout, psoriasis, syphilitic arthropathy, ochronosis, metabolic or other primary bone disease, or acute traumatic injury.