Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee
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
1 other identifier
interventional
555
1 country
37
Brief Summary
The purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg ketoprofen in Diractin®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2008
Shorter than P25 for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 24, 2008
CompletedFirst Posted
Study publicly available on registry
July 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedOctober 5, 2009
October 1, 2009
8 months
July 24, 2008
October 2, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
pain subscale of the WOMAC
week 12
Secondary Outcomes (2)
Patient global assessment of response to therapy
week 12
function subscale of the WOMAC
week 12
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IDEA AGlead
Study Sites (37)
Hope Research Institute
Phoenix, Arizona, 85016, United States
Premiere Pharmaceutical Research
Tempe, Arizona, 85282, United States
Genova Clinical Research
Tucson, Arizona, 85741, United States
Family Practice Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205, United States
Orange County Clinical Trails, Inc.
Anaheim, California, 92801, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Tampa Bay Medical Research Inc.
Clearwater, Florida, 33761, United States
University Clinical Research DeLand, LCC
DeLand, Florida, 32720, United States
Eastern Research
Hialeah, Florida, 33458, United States
DSI
Jupiter, Florida, 33458, United States
FPA Clinical Research
Kissimmee, Florida, 34741, United States
Suncoast Clinical Research Family Practice
New Port Richey, Florida, 34652, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Drug Studies America
Marietta, Georgia, 30060, United States
Non-Surgical Orthopaedic & Spine Center, P.C.
Marietta, Georgia, 30060, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Advance Clinical Research Insititute
Boise, Idaho, 83704, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Integrated Clinical Trail Services, Inc.
West Des Moines, Iowa, 50265, United States
Lousianna Research Associates Inc. (LRC, Inc)
New Orleans, Louisiana, 70114, United States
Future Care Studies
Springfield, Massachusetts, 01107, United States
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, 49009, United States
Omaha Research, P.C.
Omaha, Nebraska, 68116, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
The Center of Clinical Research LLC
Winston-Salem, North Carolina, 27103, United States
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122, United States
Pharcotherapy Research Associate, Inc.
Zanesville, Ohio, 43701, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Founders Research Group Research
Philadelphia, Pennsylvania, 19152, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Coastal Carolina Research Center
Goose Creek, South Carolina, 29445, United States
Sarah Cannon Research Institute
Jackson, Tennessee, 38305, United States
Quality Research Inc.
San Antonio, Texas, 78209, United States
Progressive Clinical Research
San Antonio, Texas, 78229, United States
Related Publications (1)
Rother M, Conaghan PG. A randomized, double-blind, phase III trial in moderate osteoarthritis knee pain comparing topical ketoprofen gel with ketoprofen-free gel. J Rheumatol. 2013 Oct;40(10):1742-8. doi: 10.3899/jrheum.130192. Epub 2013 Sep 1.
PMID: 23996292DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
IDEA AG
IDEA AG
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 24, 2008
First Posted
July 28, 2008
Study Start
June 1, 2008
Primary Completion
February 1, 2009
Study Completion
April 1, 2009
Last Updated
October 5, 2009
Record last verified: 2009-10