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

Sponsor

ZARS Pharma Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00108810

Collaborator

(none)

118

Enrollment

Locations

Arms

Duration (Months)

23.6

Patients Per Site

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Osteoarthritis, Knee	Drug: Transdermal Ketoprofen Patch with CHADD Drug: Placebo transdermal patch	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Oct 1, 2005

Actual Study Completion Date :

Oct 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transdermal Ketoprofen Patch with CHADD	Drug: Transdermal Ketoprofen Patch with CHADD 12 hours patch application for 28 days Other Names: Matrix Transdermal Ketoprofen/CHADD Sytem
Placebo Comparator: Placebo patch and a dummy heating unit	Drug: Placebo transdermal patch 12 hours application for 28 days Other Names: Placebo patch with dummy heating unit

Arm

Intervention/Treatment

Experimental: Transdermal Ketoprofen Patch with CHADD

Drug: Transdermal Ketoprofen Patch with CHADD

12 hours patch application for 28 days

Other Names:

Matrix Transdermal Ketoprofen/CHADD Sytem

Placebo Comparator: Placebo patch and a dummy heating unit

Drug: Placebo transdermal patch

12 hours application for 28 days

Other Names:

Placebo patch with dummy heating unit

Outcome Measures

Primary Outcome Measures

Change from baseline in the WOMAC pain subscale score [28 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SouthBay Pharma Research	Buena Park	California	United States	90620
2	The Center for Rheumatology and Bone Research	Washington	District of Columbia	United States	20006
3	Radiant Research	Daytona Beach	Florida	United States	32114
4	University Clinical Research	Pembroke Pines	Florida	United States	33024
5	Hospital for Special Surgery	New York City	New York	United States	10021

Sponsors and Collaborators

ZARS Pharma Inc.

Investigators

Principal Investigator: David Borenstein, MD, The Center for Rheumatology
Principal Investigator: H F Farmer, MD, Radiant Research Inc.
Principal Investigator: Larry Gilderman, DO, University Clinical Research
Principal Investigator: Soledad Lee, MD, Southbay Pharma Research
Principal Investigator: Joseph A Markenson, MD, Hospital for Special Surgery, New York