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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

July 24, 2008
October 2, 2009
June 2008
February 2009   (final data collection date for primary outcome measure)
pain subscale of the WOMAC [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00722852 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis of the Knee
  • Drug: ketoprofen in Diractin®
    100 mg (b.i.d.)
  • Drug: Placebo
    100 mg (b.i.d.)
  • Experimental: 1
    Intervention: Drug: ketoprofen in Diractin®
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
555
April 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
46 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00722852
CL-033-III-06
No
Dr. med. Matthias Rother, IDEA AG
IDEA AG
Not Provided
Study Director: IDEA AG IDEA AG
IDEA AG
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP