Overview

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

Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
352
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.