NCT04683627

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

A 12-Week, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of HP-5000 Topical System (Patch) in Subjects With Osteoarthritis Pain of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Noven Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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 to a 28-day Screening Phase that will include a Washout Period of current prescription and over the counter (OTC) analgesics; a 12-week Double-blind Treatment Phase, and a 1-week safety Follow-up Phase.

Conditions

• Osteoarthritis Pain of the Knee

Interventions

Type	Name	Description
DRUG	Diclofenac sodium active topical patch	A topical patch with diclofenac sodium as active ingredient was used and evaluated for the treatment of OA pain of the knee.
DRUG	Placebo patch	A placebo patch without diclofenac sodium was used for the placebo arm.

Timeline

• Start date: 2020-12-29
• Primary completion: 2022-07-18
• Completion: 2022-07-25
• First posted: 2020-12-24
• Last updated: 2025-09-04
• Results posted: 2025-09-04

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study