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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716547
First Posted: July 16, 2008
Last Update Posted: October 16, 2009
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.
Information provided by:
IDEA AG
  Purpose
The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by IDEA AG:

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

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

Enrollment: 1399
Study Start Date: May 2008
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
b.i.d.

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.
  Eligibility

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
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, 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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00716547


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Claudia Himly / Director of Clinical Operations, IDEA AG
ClinicalTrials.gov Identifier: NCT00716547     History of Changes
Other Study ID Numbers: CL-033-III-03
First Submitted: July 14, 2008
First Posted: July 16, 2008
Last Update Posted: October 16, 2009
Last Verified: October 2009

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