Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee

Phase 2

Completed

Interventions: Drug: Transdermal Ketoprofen Patch with CHADD
Drug: Placebo transdermal patch

Brief Summary: The purpose of the study is to evaluate the safety and effectiveness of the investigational ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance) for the treatment of pain caused by osteoarthritis.

Detailed Description: Proof-of-concept study, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of a transdermal ketoprofen patch with CHADD heat versus a placebo patch with dummy heat in patients with mild to moderate pain associated with osteoarthritis of the knee. After screening, patients discontinue all analgesic medication (except ≤325 mg aspirin daily for cardioprotective purposes). Patients selected a target knee (right or left), and all efficacy evaluations were completed with respect to this target knee. After discontinuing analgesics for at least 48 hours, and when the average pain intensity over the previous 24 hours for the target knee was ≥40 mm using a 100 mm visual analog scale (VAS), patients were randomized in a 1:1 fashion to receive treatment with either the transdermal ketoprofen patch with CHADD heat or the placebo patch with dummy heat. Patients treated the target knee each night for 12 hours (± 1 hour) for 4 weeks. Patients returned to the study site every 7 days (± 1 day) for study evaluations. Throughout the study, patients were allowed to take up to 2000 mg acetaminophen per day as rescue medication; however, rescue medication was not allowed within the 48 hours prior to efficacy evaluations.

Recruitment & Eligibility

Inclusion Criteria

Patient is between forty (40) and seventy-five (75) years of age.
Patient has clinically diagnosed radiographic evidence of osteoarthritis of the knee within the past year.

Exclusion Criteria

Patient has known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication.
Patient has a history of significant gastrointestinal disease or previous gastrointestinal upset following NSAID administration.

Arm && Interventions

Group	Intervention	Description
Transdermal Ketoprofen Patch with CHADD	Transdermal Ketoprofen Patch with CHADD	-
Placebo patch and a dummy heating unit	Placebo transdermal patch	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the WOMAC pain subscale score	28 days

Secondary Outcome Measures

Name	Time	Method
Number of participants wih adverse events	28 days
Patient Global Satisfaction score	28 days	Patient global satisfaction score at Study Visit 5
Mean change from baseline for average pain over the last 24 hours VAS scores	28 days

Locations (5): University Clinical Research
🇺🇸
Pembroke Pines, Florida, United States
The Center for Rheumatology and Bone Research
🇺🇸
Washington, District of Columbia, United States
Hospital for Special Surgery
🇺🇸
New York City, New York, United States
SouthBay Pharma Research
🇺🇸
Buena Park, California, United States
Radiant Research
🇺🇸
Daytona Beach, Florida, United States