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

Noven Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis of the Knee

Treatments: Drug: Diclofenac Sodium Active Topical Patch 2; Drug: Diclofenac Sodium Active Topical Patch 1; Drug: Placebo patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT03277066

HP-5000-US-05

Details and patient eligibility

About

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

Full 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.

Enrollment: 289 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 (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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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289 participants in 2 patient groups

Diclofenac Sodium Active Topical Patch 1

Experimental group

Description:

Diclofenac sodium 1 topical patches will be compared against placebo patches.

Treatment:

Drug: Placebo patch

Drug: Diclofenac Sodium Active Topical Patch 1

Diclofenac Sodium Active Topical Patch 2

Experimental group

Description:

Diclofenac sodium 2 topical patches will be compared against placebo patches.

Treatment:

Drug: Placebo patch

Drug: Diclofenac Sodium Active Topical Patch 2