Pain, Osteoarthritis, Knee
Conditions
Keywords
Pain, Osteoarthritis, OA, Mild to Moderate Osteoarthritis (OA) Pain of the Knee
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.
Interventions
DRUGTransdermal Ketoprofen Patch with CHADD
12 hours patch application for 28 days
12 hours application for 28 days
Sponsors
ZARS Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the WOMAC pain subscale score | 28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline for average pain over the last 24 hours VAS scores | 28 days | — |
| Number of participants wih adverse events | 28 days | — |
| Patient Global Satisfaction score | 28 days | Patient global satisfaction score at Study Visit 5 |
Countries
United States
Outcome results
None listed