NCT03277066

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: Noven Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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 Screening Phase that will include a Washout Period of current prescription and over the counter (OTC) analgesics, a 4-week double-blind Treatment Phase, and a 1-week safety Follow-up Period.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	Diclofenac Sodium Active Topical Patch 1	HP-5000 Active Topical Patch 1 were applied on subjects with Osteoarthritis of the knee(s)
DRUG	Diclofenac Sodium Active Topical Patch 2	HP-5000 Active Topical Patch 2 were applied on subjects with Osteoarthritis of the knee(s)
DRUG	Placebo patch	Topical placebo patches were applied on subjects with Osteoarthritis of the knee(s)

Timeline

• Start date: 2017-09-07
• Primary completion: 2019-09-25
• Completion: 2019-09-25
• First posted: 2017-09-08
• Last updated: 2021-12-23
• Results posted: 2021-12-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study