The Randomized Etoricoxib Study in Patients With Osteoarthritis Not Responding to Analgesic Drugs - THE RESPOND-EUROPE STUDY

NCT01429168 Phase 4 WITHDRAWN

This two-part study will evaluate the effectiveness of etoricoxib in controlling pain in participants with osteoarthritis who are experiencing inadequate response to their current treatments. In Part 1, all participants will receive open-label etoricoxib 60 mg daily. Those participants who experience a clinically meaningful response to etoricoxib 60 mg daily within two weeks will be eligible to enter the double-blind withdrawal period (Part II). Responders entering Part 2 will be randomized in a 1:1 ratio to receive either etoricoxib 60 mg or placebo.

Details

Lead sponsor	Organon and Co
Phase	Phase 4
Status	WITHDRAWN
Start date	2011-10
Completion	2012-08

Conditions

• Osteoarthritis

Interventions

• Etoricoxib
• Placebo for etoricoxib

Primary outcomes

• Mean Time to Loss of Efficacy in the Double Blind Withdrawal Period (Part 2) — Week 3 to Week 7