Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee

Osteoarthritis of the Knee Clinical Trial

Official title:

Multicentre, Randomized, Double-blind, Placebo-controlled Study of Safety and Efficacy of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00722852
• Other study ID #: CL-033-III-06
• Status: Completed
• Phase: Phase 3
• First received: July 24, 2008
• Last updated: October 2, 2009
• Start date: June 2008
• Est. completion date: April 2009

Study information

• Verified date: October 2009
• Source: IDEA AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg ketoprofen in Diractin®.

Description:

The study will investigate safety and efficacy of Diractin® at relieving signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 555
• Est. completion date: April 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 46 Years and older

Eligibility

Inclusion Criteria:

• Informed consent signed and dated

• Age > 45 years

• Class I-III OA of the knee and subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee

Exclusion Criteria:

• Skin lesions or dermatological diseases in the treatment area

• Directly or indirectly involved in the conduct and administration of this study

• Received any investigational medicinal product within 30 days prior to Screening Visit or participation in any previous clinical study with Diractin®

• Pregnancy or lactation

• Residents of psychiatric wards, prisons or other state institutions

• Malignancy within the past 2 years

• Depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study

• Epilepsy

• Schizophrenia

• Neuropathic pain and any other pain condition requiring chronic use of pain medication

• Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen and to ingredients of the IMP

• Preexisting asthma or bronchospasm after taking aspirin or other NSAIDs

• Unable to discontinue analgesic therapy including opioids, NSAID´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study

Study Design

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• ketoprofen in Diractin®
100 mg (b.i.d.)
• Placebo
100 mg (b.i.d.)

Locations

Country	Name	City	State
United States	Orange County Clinical Trails, Inc.	Anaheim	California
United States	Advance Clinical Research Insititute	Boise	Idaho
United States	Tampa Bay Medical Research Inc.	Clearwater	Florida
United States	Rapid Medical Research, Inc.	Cleveland	Ohio
United States	University Clinical Research DeLand, LCC	Deland	Florida
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	MediSphere Medical Research Center, LLC	Evansville	Indiana
United States	Coastal Carolina Research Center	Goose Creek,	South Carolina
United States	Eastern Research	Hialeah	Florida
United States	Sarah Cannon Research Institute	Jackson	Tennessee
United States	DSI	Jupiter	Florida
United States	Westside Family Medical Center, P.C.	Kalamazoo	Michigan
United States	FPA Clinical Research	Kissimmee	Florida
United States	Family Practice Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	Drug Studies America	Marietta	Georgia
United States	Non-Surgical Orthopaedic & Spine Center, P.C.	Marietta,	Georgia
United States	Lousianna Research Associates Inc. (LRC, Inc)	New Orleans,	Louisiana
United States	Suncoast Clinical Research Family Practice	New Port Richey,	Florida
United States	Renstar Medical Research	Ocala	Florida
United States	Omaha Research, P.C.	Omaha	Nebraska
United States	University Clinical Research, Inc.	Pembroke Pines	Florida
United States	Founders Research Group Research	Philadelphia	Pennsylvania
United States	Hope Research Institute	Phoenix	Arizona
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	Rochester Clinical Research	Rochester	New York
United States	Progressive Clinical Research	San Antonio	Texas
United States	Quality Research Inc.	San Antonio	Texas
United States	Miami Research Associates	South Miami	Florida
United States	Encompass Clinical Research	Spring Valley,	California
United States	Future Care Studies	Springfield	Massachusetts
United States	Clinical Research Atlanta	Stockbridge,	Georgia
United States	Premiere Pharmaceutical Research	Tempe	Arizona
United States	Genova Clinical Research	Tucson	Arizona
United States	Omega Medical Research	Warwick	Rhode Island
United States	Integrated Clinical Trail Services, Inc.	West Des Moines	Iowa
United States	The Center of Clinical Research LLC	Winston-Salem	North Carolina
United States	Pharcotherapy Research Associate, Inc.	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
IDEA AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain subscale of the WOMAC		week 12	No
Secondary	Patient global assessment of response to therapy		week 12	No
Secondary	function subscale of the WOMAC		week 12	No