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

This study has been completed.
Sponsor:
Information provided by:
IDEA AG
ClinicalTrials.gov Identifier:
NCT00716547
First received: July 14, 2008
Last updated: October 15, 2009
Last verified: October 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ 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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by IDEA AG

Additional 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
Study First Received: July 14, 2008
Last Updated: October 15, 2009
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

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

ClinicalTrials.gov processed this record on August 25, 2014