Ketoprofen in Transfersome Compared to Oral Celecoxib and Placebo for Pain Associated With Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by:
IDEA AG
ClinicalTrials.gov Identifier:
NCT00317733
First received: April 21, 2006
Last updated: March 19, 2009
Last verified: March 2009
  Purpose

The purpose of this study is to determine the safety and effectiveness of 110 mg ketoprofen in Transfersome applied to the skin twice daily as compared to placebo and oral celecoxib 200 mg per day for the relief of signs and symptoms of osteoarthritis of the knee for a period of six weeks.


Condition Intervention Phase
Osteoarthritis, Knee
Drug: Ketoprofen in Transfersome
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Evaluation of Safety and Efficacy of Epicutaneously Applied IDEA-033 (Ketoprofen in Transfersome) in Comparison to Oral Celecoxib for the Treatment of Pain Associated With Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by IDEA AG:

Primary Outcome Measures:
  • Change from baseline at Week 6 on the VAS version of the WOMAC pain subscale; Change from baseline at Week 6 on the VAS version of the WOMAC function subscale; Subject global assessment of response to therapy measured on a 5-point Likert scale at Week 6

Secondary Outcome Measures:
  • Change from baseline at Weeks 2 and 4 for WOMAC pain and physical function scores; Subject global assessment of response to therapy at Weeks 2 and 4; Physician's global assesment of osteoarthritis at Weeks 2, 4 and 6

Estimated Enrollment: 360
Estimated Study Completion Date: January 2004
Detailed Description:

This is a multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), double-dummy, parallel group, placebo- and active-controlled study to determine the safety and effectiveness of 110 mg of ketoprofen in Transfersome, applied to the skin, in subjects experiencing at least moderate pain when not taking analgesic medication secondary to osteoarthritis pain of the knee. The study hypothesis is that ketoprofen in Transfersome applied to the skin twice daily will be more effective than placebo for the relief of the signs and symptoms of osteoarthritis of the knee as measured by the Visual Analog Scale (VAS) of the Western Ontario and McMaster Universities Index (WOMAC) pain, WOMAC function and subject global asessment of response to therapy at Week 6. WOMAC is a questionaire consisting of 24 questions designed to assess the three dimensions of pain, disability and joint stiffness in osteoarthritis of the knee. Safety evaluations include reports of adverse events, laboratory tests and skin irritation.

Patients will receive one of the following treatments for six weeks - 110 mg ketoprofen in Transfersome applied to the skin twice per day plus one placebo capsule administered orally twice per day, 100 mg celecoxib administered orally twice per day plus placebo Transfersome applied to the skin twice per day, Placebo Transfersome applied to the skin twice per day plus one placebo capsule administered orally twice twice per day.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthritis of the knee for a minimum of six months
  • Patient´s rating of pain in the index knee while not taking oral NSAIDs of at least 3 using a 5-point Likert scale
  • Presenting two out of the three following criteria - Morning stiffness of less than 30 minutes duration, Crepitus on motion, Age >= 40 years
  • Patients must have used oral NSAIDs at least 3 days per week for the 3 months prior to screening or the patient was taking an NSAID on a regular basis (>25 out of 30 days) at a therapeutic level for at least 30 days prior to screening
  • Each of the following three criteria (the osteoarthritis flare criteria) must be met - Index knee pain assessment at walking at least 40 mm on VAS at baseline, Increase of index knee pain at walking by at least 15 mm on VAS at baseline compared to screening, Physician´s global assessment of osteoarthritis 3-5 and at least 1 grade increase from screening

Exclusion Criteria:

  • Grade 1 or Grade 4 severity of the index knee based on Kellgren and Lawrence radiographic criteria
  • Intraarticular injections or arthroscopy of the index knee within 3 months prior to screening
  • Signs of any clinically important inflammation of the index knee including redness, warmth and or a large bulging effusion with the loss of normal contour
  • Crystalline-induced synovitis in the index knee
  • History, physical examination or radiographic suggestive of acute inflammatory arthritis, rheumatoid arthritis, psoriatic arthritis, septic arthritis, gout, pseudogout, fibromyalgia, lupus erythematosus, or other types of inflammatory arthritis of the index knee
  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: NCT00317733

Sponsors and Collaborators
IDEA AG
Investigators
Study Director: McNeil Consumer & Specialty Pharmaceuticals Clinical Trial McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00317733     History of Changes
Obsolete Identifiers: NCT01309464
Other Study ID Numbers: CL-033-II-03
Study First Received: April 21, 2006
Last Updated: March 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by IDEA AG:
Ketoprofen
Transfersome
Osteoarthritis, Knee

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

ClinicalTrials.gov processed this record on October 22, 2014