A Long-Term Safety Study of IDEA-033 in Comparison to Oral Naproxen for

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00265304
Study type	Interventional
Source	IDEA AG
Contact
Status	Completed
Phase	Phase 2
Start date	July 2005

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Long-Term Safety Study of IDEA-033 in Comparison to Oral Naproxen for the Treatment of Osteoarthritis of the Knee

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms