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

This study has been completed.
Sponsor:
Information provided by:
IDEA AG
ClinicalTrials.gov Identifier:
NCT00722852
First received: July 24, 2008
Last updated: October 2, 2009
Last verified: October 2009
History of Changes
  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 3

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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Ketoprofen
U.S. FDA Resources

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 ]

Enrollment: 555
Study Start Date: June 2008
Study Completion Date: April 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ketoprofen in Diractin®
100 mg (b.i.d.)
Placebo Comparator: 2 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

  Hide Study Locations
Locations
United States, Arizona
Hope Research Institute
Phoenix, Arizona, United States, 85016
Premiere Pharmaceutical Research
Tempe, Arizona, United States, 85282
Genova Clinical Research
Tucson, Arizona, United States, 85741
United States, Arkansas
Family Practice Lynn Institute of the Ozarks
Little Rock, Arkansas, United States, 72205
United States, California
Orange County Clinical Trails, Inc.
Anaheim, California, United States, 92801
Encompass Clinical Research
Spring Valley,, California, United States, 91978
United States, Florida
Tampa Bay Medical Research Inc.
Clearwater, Florida, United States, 33761
University Clinical Research DeLand, LCC
Deland, Florida, United States, 32720
Eastern Research
Hialeah, Florida, United States, 33458
DSI
Jupiter, Florida, United States, 33458
FPA Clinical Research
Kissimmee, Florida, United States, 34741
Suncoast Clinical Research Family Practice
New Port Richey,, Florida, United States, 34652
Renstar Medical Research
Ocala, Florida, United States, 34471
University Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33024
Miami Research Associates
South Miami, Florida, United States, 33143
United States, Georgia
Drug Studies America
Marietta, Georgia, United States, 30060
Non-Surgical Orthopaedic & Spine Center, P.C.
Marietta,, Georgia, United States, 30060
Clinical Research Atlanta
Stockbridge,, Georgia, United States, 30281
United States, Idaho
Advance Clinical Research Insititute
Boise, Idaho, United States, 83704
United States, Indiana
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
United States, Iowa
Integrated Clinical Trail Services, Inc.
West Des Moines, Iowa, United States, 50265
United States, Louisiana
Lousianna Research Associates Inc. (LRC, Inc)
New Orleans,, Louisiana, United States, 70114
United States, Massachusetts
Future Care Studies
Springfield, Massachusetts, United States, 01107
United States, Michigan
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, United States, 49009
United States, Nebraska
Omaha Research, P.C.
Omaha, Nebraska, United States, 68116
United States, New York
Rochester Clinical Research
Rochester, New York, United States, 14609
United States, North Carolina
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
The Center of Clinical Research LLC
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Rapid Medical Research, Inc.
Cleveland, Ohio, United States, 44122
Pharcotherapy Research Associate, Inc.
Zanesville, Ohio, United States, 43701
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Founders Research Group Research
Philadelphia, Pennsylvania, United States, 19152
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Coastal Carolina Research Center
Goose Creek,, South Carolina, United States, 29445
United States, Tennessee
Sarah Cannon Research Institute
Jackson, Tennessee, United States, 38305
United States, Texas
Progressive Clinical Research
San Antonio, Texas, United States, 78229
Quality Research Inc.
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
IDEA AG
Investigators
Study Director: IDEA AG IDEA AG
  More Information

No publications provided

Responsible Party: Dr. med. Matthias Rother, IDEA AG
ClinicalTrials.gov Identifier: NCT00722852     History of Changes
Other Study ID Numbers: CL-033-III-06
Study First Received: July 24, 2008
Last Updated: October 2, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 13, 2013