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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00108810
• Other study ID #: ZMK-202
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2005
• Last updated: May 30, 2012
• Start date: April 2005
• Est. completion date: October 2005

Study information

• Verified date: May 2012
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Pain

Intervention

Drug:
• Transdermal Ketoprofen Patch with CHADD
12 hours patch application for 28 days
• Placebo transdermal patch
12 hours application for 28 days

Locations

Country	Name	City	State
United States	SouthBay Pharma Research	Buena Park	California
United States	Radiant Research	Daytona Beach	Florida
United States	Hospital for Special Surgery	New York City	New York
United States	University Clinical Research	Pembroke Pines	Florida
United States	The Center for Rheumatology and Bone Research	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the WOMAC pain subscale score		28 days	No
Secondary	Number of participants wih adverse events		28 days	Yes
Secondary	Patient Global Satisfaction score	Patient global satisfaction score at Study Visit 5	28 days	No
Secondary	Mean change from baseline for average pain over the last 24 hours VAS scores		28 days	No