Status:
COMPLETED
A 12-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Osteoarthritis Pain of the Knee
Lead Sponsor:
Noven Pharmaceuticals, Inc.
Conditions:
Osteoarthritis Pain of the Knee
Eligibility:
All Genders
40-85 years
Phase:
PHASE3
Brief 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
Detailed Description
This is a multi-center, randomized, double-blind, and placebo-controlled phase 3 study evaluating the safety and efficacy of HP-5000 in subjects with OA pain of the knees. The study will consist of up...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2022
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT04683627
Start Date
December 29 2020
End Date
July 25 2022
Last Update
September 4 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Applied Research Center of Arkansas
Little Rock, Arkansas, United States, 72212
2
Clinical Research of West Florida,Inc.
Clearwater, Florida, United States, 33765
3
Universal Axon Clinical Research, LLC
Doral, Florida, United States, 33166
4
The Arthritis and Diabetes Clinic, Inc.
Monroe, Louisiana, United States, 71203