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

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis Pain of the Knee

In brief

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

Key facts

Study ID

NCT04683627

Run by

Noven Pharmaceuticals, Inc.

People needed

370

Starts

2020-12-29

Expected to finish

2022-07-25

Last updated by the study team

2025-09-04

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Applied Research Center of Arkansas — Little Rock, Arkansas, United States
• Clinical Research of West Florida,Inc. — Clearwater, Florida, United States
• Universal Axon Clinical Research, LLC — Doral, Florida, United States
• The Arthritis and Diabetes Clinic, Inc. — Monroe, Louisiana, United States
• Noven Pharmaceuticals, Inc. — Jersey City, New Jersey, United States
• Velocity Clinical Research — Cincinnati, Ohio, United States
• Partners in Clinical Research — Cumberland, Rhode Island, United States
• Palmetto Clinical Research — Summerville, South Carolina, United States
• Metroplex Clinical Research Center — Dallas, Texas, United States
• Quality Research Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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