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

Osteoarthritis Pain of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04640675
• Other study ID #: HP-5000-US-07
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2020
• Est. completion date: December 2022

Study information

• Verified date: November 2020
• Source: Noven Therapeutics
• Contact: HP-5000 Project Team
• Phone: (551) 233-2656
• Email: HP5000[@]noven.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 352
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Pain of the Knee

Intervention

Drug:
• Diclofenac sodium active topical patch
A topical patch with diclofenac sodium will be evaluated against the placebo patch for the treatment of OA pain of the knee
• Placebo patch
A placebo patch without diclofenac sodium will be used for the placebo arm.

Locations

Country	Name	City	State
United States	Noven Pharmaceuticals, Inc.	Jersey City	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Noven Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in Osteoarthritis of the Knee pain score between Baseline and Week 12.	Primary efficacy endpoint	12-week vs. baseline