Status:
COMPLETED
A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis
Lead Sponsor:
Noven Pharmaceuticals, Inc.
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
Brief Summary
A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) of the Knee
Detailed Description
This is a multicenter, randomized, double-blind, and placebo-controlled phase 2 study evaluating 2 formulations of HP-5000 in subjects with OA of the knee. The study will consist of up to 28-day Scree...
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 (ACR) criteria, including:
- Symptoms for at least 6 months prior to screening, AND
- Knee pain in the target knee for 30 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.) AND
- The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs (NSAIDs) either over the counter (OTC) per recommendation of a physician or prescribed.
Exclusion
- Body mass index (BMI) \> 40
- Any subject who disobeyed the restriction of prohibited therapies (i.e., use rescue medication) during Screening Washout Period.
- Secondary OA of the knee (rheumatoid arthritis, gout, psoriasis, syphilitic neuropathy, ochronosis, metabolic or other primary bone disease or acute trauma).
Key Trial Info
Start Date :
September 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2019
Estimated Enrollment :
289 Patients enrolled
Trial Details
Trial ID
NCT03277066
Start Date
September 7 2017
End Date
September 25 2019
Last Update
December 23 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Noven Pharmaceuticals, Inc.
Jersey City, New Jersey, United States, 07310