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

Noven Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis Pain of the Knee

Treatments: Drug: Placebo patch; Drug: Diclofenac sodium active topical patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT04683627

HP-5000-US-07

Details and patient eligibility

About

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

Full 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.

Enrollment: 370 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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370 participants in 2 patient groups, including a placebo group

HP-5000 Treatment

Experimental group

Description:

HP-5000 Topical Patch will be evaluated against placebo topical patches.

Treatment:

Drug: Diclofenac sodium active topical patch

Placebo Treatment

Placebo Comparator group

Description:

Placebo patches without diclofenac sodium will be used.

Treatment:

Drug: Placebo patch