A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis of the Knee

In brief

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

Key facts

Study ID

NCT03277066

Run by

Noven Pharmaceuticals, Inc.

People needed

289

Starts

2017-09-07

Expected to finish

2019-09-25

Last updated by the study team

2021-12-23

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 (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.

You may not qualify if…

• 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).

Where it is running

• Noven Pharmaceuticals, Inc. — Jersey City, New Jersey, United States

Full record on ClinicalTrials.gov

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