Clinical trial NCT00722852: Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Lead sponsor: IDEA AG
Sponsor class: INDUSTRY
First posted: 2008-07-28
Enrollment: 555
Sex: ALL
Minimum age (years): 46
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: pain subscale of the WOMAC
timeFrame: week 12
Secondary outcomes:
measure: Patient global assessment of response to therapy
timeFrame: week 12
measure: function subscale of the WOMAC
timeFrame: week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Tempe
country: United States
facility: Premiere Pharmaceutical Research
state: Arizona
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Family Practice Lynn Institute of the Ozarks
state: Arkansas
city: Anaheim
country: United States
facility: Orange County Clinical Trails, Inc.
state: California
city: Spring Valley,
country: United States
facility: Encompass Clinical Research
state: California
city: Clearwater
country: United States
facility: Tampa Bay Medical Research Inc.
state: Florida
city: Deland
country: United States
facility: University Clinical Research DeLand, LCC
state: Florida
city: Hialeah
country: United States
facility: Eastern Research
state: Florida
city: Jupiter
country: United States
facility: DSI
state: Florida
city: Kissimmee
country: United States
facility: FPA Clinical Research
state: Florida
city: New Port Richey,
country: United States
facility: Suncoast Clinical Research Family Practice
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Marietta,
country: United States
facility: Non-Surgical Orthopaedic & Spine Center, P.C.
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Stockbridge,
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Boise
country: United States
facility: Advance Clinical Research Insititute
state: Idaho
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: West Des Moines
country: United States
facility: Integrated Clinical Trail Services, Inc.
state: Iowa
city: New Orleans,
country: United States
facility: Lousianna Research Associates Inc. (LRC, Inc)
state: Louisiana
city: Springfield
country: United States
facility: Future Care Studies
state: Massachusetts
city: Kalamazoo
country: United States
facility: Westside Family Medical Center, P.C.
state: Michigan
city: Omaha
country: United States
facility: Omaha Research, P.C.
state: Nebraska
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center of Clinical Research LLC
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Zanesville
country: United States
facility: Pharcotherapy Research Associate, Inc.
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Founders Research Group Research
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Goose Creek,
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Jackson
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: San Antonio
country: United States
facility: Quality Research Inc.
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
Study officials:
affiliation: IDEA AG
name: IDEA AG
role: STUDY_DIRECTOR
References:
citation: 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.