Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00716547
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : October 16, 2009
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Brief Summary:
The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: ketoprofen in Diractin® Drug: Placebo Drug: celecoxib Phase 3

Detailed Description:
The study will investigate safety and efficacy of 2 dosages of Diractin®at relieving the signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1399 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Study of Safety and Efficacy of Two Dosages of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee
Study Start Date : May 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 1 Drug: ketoprofen in Diractin®
50 mg (b.i.d.)
Experimental: 2 Drug: ketoprofen in Diractin®
100 mg (b.i.d.)
Active Comparator: 3 Drug: celecoxib
100 mg (b.i.d.)
Placebo Comparator: 4 Drug: Placebo

Primary Outcome Measures :
  1. pain subscale of the WOMAC [ Time Frame: week 12 ]

Secondary Outcome Measures :
  1. Patient global assessment of response to therapy [ Time Frame: week 12 ]
  2. function subscale of the WOMAC [ Time Frame: week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   46 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, celecoxib, sulfonamides and ingredients used in pharmaceutical products including galactose
  • Peripheral arterial disease and/or cerebrovascular disease
  • History of stroke or myocardial infarction
  • Congestive Heart failure NYHA Class II-IV
  • History of pancreatitis or peptic ulcers;
  • Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa)
  • Serum creatinine levels > 2.5 milligrams/deciliter (mg/dL)
  • ALT or AST levels ≥ 5 times the ULN
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00716547

Czech Republic
IDEA Investigational Site
Prague 2, Czech Republic, 128 50
Wiesbaden, Germany, 65191
NZOZ Nasz Lekarz
Torun, Poland, 87-100
United Kingdom
Chapel Allerton Hospital
Leeds, United Kingdom, LS7 4SA
Sponsors and Collaborators
Study Director: IDEA AG Clinical Trial IDEA AG

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Claudia Himly / Director of Clinical Operations, IDEA AG Identifier: NCT00716547     History of Changes
Other Study ID Numbers: CL-033-III-03
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: October 16, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents