A Long-Term Safety Study of IDEA-033 in Comparison to Oral Naproxen for the Treatment of Osteoarthritis of the Knee
The purpose of this study is to evaluate the long-term safety of IDEA-033 (an anti-inflammatory pain-relieving drug applied to the skin) in comparison to naproxen (an anti-inflammatory pain-relieving drug taken by mouth) for the treatment of osteoarthritis of both knees.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Long-Term Evaluation of the Safety of IDEA-033 in Comparison to Oral Naproxen for the Treatment of the Signs and Symptoms of Osteoarthritis of the Knee|
- Adverse events; Dermal-irritation scores; Changes in routine clinical laboratory tests and vital signs obtained at each visit.
- Change from baseline (Week 12 for patients who completed 17-007, baseline for those who did not) and mean value per visit for WOMAC pain, stiffness, and physical function scores; Subject Global Assessment of Response to Therapy.
|Study Start Date:||July 2005|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
This is a double-blind, active-controlled study of the safety of IDEA-033 in comparison to oral naproxen for the treatment of the signs and symptoms of osteoarthritis of the knee in patients who have completed Study 17-007 or who have discontinued Study 17-007 due to lack of efficacy. If a sufficient number of patients do not enroll from Study 17-007, patients with osteoarthritis of both knees who were not enrolled in Study 17-007 may be enrolled in this study. Patients treated with IDEA-033 in Study 17-007 will receive 100 mg per knee of ketoprofen gel twice daily and one placebo capsule twice daily for 52 weeks. Patients treated with oral naproxen or placebo in Study 17-007 will receive a 500 mg naproxen over-encapsulated tablet twice daily and placebo topical gel twice daily for 52 weeks. Patients who did not participate in Study 17-007 will be randomized to receive one of these two treatments. The primary outcomes of the study include the incidence and severity of adverse events, dermal-irritation scores, and changes in routine clinical laboratory tests and vital signs obtained at each visit.
Patients assigned to IDEA-033 in Study 17-007 will topically apply 100 mg per knee of ketoprofen gel twice daily and take one oral placebo capsule twice daily for 52 weeks. Patients assigned to oral naproxen or placebo in Study 17-007 will take one 500 mg naproxen over-encapsulated tablet orally twice daily and apply placebo topical gel twice daily for 52 weeks. Patients who did not participate in Study 17-007 will be randomized to receive one of these two treatments.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265304
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|Study Director:||IDEA AG Clinical Trial||IDEA AG|