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

NCT00317733 | Completed Phase 2

• 1 other identifier: CL-033-II-03
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

Ketoprofen; Transfersome; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

Ketoprofen in Transfersome DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IDEA AG: lead

Related Publications (1)

• Rother M, Lavins BJ, Kneer W, Lehnhardt K, Seidel EJ, Mazgareanu S. Efficacy and safety of epicutaneous ketoprofen in Transfersome (IDEA-033) versus oral celecoxib and placebo in osteoarthritis of the knee: multicentre randomised controlled trial. Ann Rheum Dis. 2007 Sep;66(9):1178-83. doi: 10.1136/ard.2006.065128. Epub 2007 Mar 15.

  PMID: 17363401 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ketoprofen

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• McNeil Consumer & Specialty Pharmaceuticals Clinical Trial

  McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 21, 2006
• First Posted: April 25, 2006
• Study Completion: January 1, 2004
• Last Updated: March 20, 2009

Record last verified: 2009-03