Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee - Full Text View

Sponsored by:	IDEA AG
Information provided by:	IDEA AG
ClinicalTrials.gov Identifier:	NCT00722852

Purpose

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

Condition	Intervention	Phase
Osteoarthritis of the Knee	Drug: ketoprofen in Diractin® Drug: Placebo	Phase III

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Ketoprofen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by IDEA AG:

Primary Outcome Measures:

pain subscale of the WOMAC [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient global assessment of response to therapy [ Time Frame: week 12 ] [ Designated as safety issue: No ]
function subscale of the WOMAC [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	June 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ketoprofen in Diractin® 100 mg (b.i.d.)
2: Placebo Comparator	Drug: Placebo 100 mg (b.i.d.)

Detailed 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.

Eligibility

Ages Eligible for Study:	46 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722852

Locations

United States, California
Encompass Clinical Research	Recruiting
Spring Valley,, California, United States, 91978
Contact: Robert Lipetz 619-660-9068
Principal Investigator: Robert Lipetz,
United States, Florida
Suncoast Clinical Research Family Practice	Recruiting
New Port Richey,, Florida, United States, 34652
Contact: Lisa Cohen 727-849-4431
Principal Investigator: Lisa Cohen,
United States, Georgia
Non-Surgical Orthopaedic & Spine Center, P.C.	Recruiting
Marietta,, Georgia, United States, 30060
Contact: Arnold Weil 770-421-2030
Principal Investigator: Arnold Weil,
Clinical Research Atlanta	Recruiting
Stockbridge,, Georgia, United States, 30281
Contact: Gary Vogin 770-507-6867
Principal Investigator: Gary Vogin,
Drug Studies America	Recruiting
Marietta, Georgia, United States, 30060
Contact: Marvin Tark 678-581-5252
Principal Investigator: Marvin Tark
United States, Louisiana
Lousianna Research Associates Inc. (LRC, Inc)	Recruiting
New Orleans,, Louisiana, United States, 70114
Contact: Michael Biunno 504-363-7448
Principal Investigator: Michael Biunno,
United States, New York
Research Across America	Recruiting
New York,, New York, United States, 10022
Contact: Howard Adelglass 212-751-3242
Principal Investigator: Howard Adelglass,
United States, South Carolina
Coastal Carolina Research Center	Recruiting
Goose Creek,, South Carolina, United States, 29445
Contact: Patricia Campbell 814-693-0300
Principal Investigator: Patricia Campbell,

Sponsors and Collaborators

IDEA AG

Investigators

Study Director:

IDEA AG

More Information

Responsible Party:	IDEA AG ( Dr. med. Matthias Rother )
Study ID Numbers:	CL-033-III-06
Study First Received:	July 24, 2008
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00722852
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Ketoprofen
Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009