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Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)
This study is currently recruiting participants.
Verified by IDEA AG, December 2008
Sponsored by: IDEA AG
Information provided by: IDEA AG
ClinicalTrials.gov Identifier: NCT00716547
  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 III

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide Ketoprofen
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by IDEA AG:

Primary Outcome Measures:
  • pain subscale of the WOMAC [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1320
Study Start Date: May 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: ketoprofen in Diractin®
50 mg (b.i.d.)
2: Experimental Drug: ketoprofen in Diractin®
100 mg (b.i.d.)
3: Active Comparator Drug: celecoxib
100 mg (b.i.d.)
4: Placebo Comparator 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

Ages Eligible for Study:   46 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716547

Locations
Czech Republic
IDEA Investigational Site Recruiting
Prague 2, Czech Republic, 128 50
Contact: Karel Pavelka, Prof. M.D.     +49-89-324633-0     idea@idea-ag.de    
Principal Investigator: Karel Pavelka, Prof. M.D.            
Germany
Klaus-Miehlke-Klinik Recruiting
Wiesbaden, Germany, 65191
Contact: Wolfgang Bolten, M.D.     +49-89-324633-0     idea@idea-ag.de    
Principal Investigator: Wolfgang Bolten, M.D.            
Poland
NZOZ Nasz Lekarz Recruiting
Torun, Poland, 87-100
Contact: Slawomir Jeka, M.D.     +49-89-324633-0     idea@idea-ag.de    
Principal Investigator: Slawomir Jeka, M.D.            
United Kingdom
Chapel Allerton Hospital Recruiting
Leeds, United Kingdom, LS7 4SA
Contact: Philip Conaghan, MB BS PhD FRACP FRCP     +49-89-324633-0     idea@idea-ag.de    
Principal Investigator: Philip Conaghan, MB BS PhD FRACP FRCP            
Sponsors and Collaborators
IDEA AG
Investigators
Study Director: IDEA AG Clinical Trial IDEA AG
  More Information

Responsible Party: IDEA AG ( Dr. Claudia Himly / Director of Clinical Operations )
Study ID Numbers: CL-033-III-03
Study First Received: July 14, 2008
Last Updated: December 4, 2008
ClinicalTrials.gov Identifier: NCT00716547  
Health Authority: United States: Food and Drug Administration;   Germany: Federal Institute for Drugs and Medical Devices;   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   United Kingdom: National Health Service;   United Kingdom: Research Ethics Committee;   Czech Republic: Ethics Committee;   Czech Republic: State Institute for Drug Control;   Poland: Ministry of Health;   Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Study placed in the following topic categories:
Ketoprofen
Osteoarthritis, Knee
Celecoxib
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009