Clinical trial NCT00108810: Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee
Official title: Randomized, Double-Blind, Parallel, Placebo Controlled 4 Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of Transdermal Ketoprofen When Administered With Controlled Heat in Patients With Mild to Moderate OA Pain of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Osteoarthritis, Knee
Keywords: Pain
Osteoarthritis
OA
Mild to Moderate Osteoarthritis (OA) Pain of the Knee
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2005-04-19
Enrollment: 118
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in the WOMAC pain subscale score
timeFrame: 28 days
Secondary outcomes:
measure: Number of participants wih adverse events
timeFrame: 28 days
measure: Patient Global Satisfaction score
timeFrame: 28 days
measure: Mean change from baseline for average pain over the last 24 hours VAS scores
timeFrame: 28 days
Other outcomes:
Locations:
city: Buena Park
country: United States
facility: SouthBay Pharma Research
state: California
city: Washington
country: United States
facility: The Center for Rheumatology and Bone Research
state: District of Columbia
city: Daytona Beach
country: United States
facility: Radiant Research
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research
state: Florida
city: New York City
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: The Center for Rheumatology
name: David Borenstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research Inc.
name: H F Farmer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Clinical Research
name: Larry Gilderman, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Southbay Pharma Research
name: Soledad Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Special Surgery, New York
name: Joseph A Markenson, MD
role: PRINCIPAL_INVESTIGATOR
References: