NCT02594176 - Clinical Trial References

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.

Citation(s)

Conaghan PG, Dickson J, Bolten W, Cevc G, Rother M
A multicentre, randomized, placebo- and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with osteoarthritis. Rheumatology (Oxford). 2013 Jul;52(7):1303-12. doi: 10.1093/rheumatology/ket133. Epub 2013 Mar 28.
Kneer W, Rother M, Mazgareanu S, Seidel EJ; European IDEA-033 study group
A 12-week randomized study of topical therapy with three dosages of ketoprofen in Transfersome® gel (IDEA-033) compared with the ketoprofen-free vehicle (TDT 064), in patients with osteoarthritis of the knee. J Pain Res. 2013 Oct 25;6:743-53. doi: 10.2147/JPR.S51054. eCollection 2013.
Rother M, Conaghan PG
A randomized, double-blind, phase III trial in moderate osteoarthritis knee pain comparing topical ketoprofen gel with ketoprofen-free gel. J Rheumatol. 2013 Oct;40(10):1742-8. doi: 10.3899/jrheum.130192. Epub 2013 Sep 1.

A Randomised, Double-blind, Placebo Controlled Study of Topical FLEXISEQ® for the Treatment of Osteoarthritis of the Knee in Patients Contraindicated for or With Clinical Intolerance to NSAIDs

Details for clinical trial NCT02594176

Clinical trial NCT02594176 - References