NCT00264147

Rheumatoid Arthritis Dose Ranging Study (0663-086)(COMPLETED)

A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Parallel-Group, 12-Week Study to Assess the Clinically Effective Dose Range of Etoricoxib and to Assess Its Safety and Tolerability in Patients With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 761 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the clinically active dose range of study medication in the treatment of patients with rheumatoid arthritis.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	etoricoxib	Period I: Arm 1: etoricoxib 10 mg tablet once daily. 12 weeks of treatment.
DRUG	etoricoxib	Period I: Arm 2: etoricoxib 30 mg tablet once daily. 12 weeks of treatment.
DRUG	etoricoxib	Period I: Arm 3: etoricoxib 60 mg tablet once daily. 12 weeks of treatment.
DRUG	etoricoxib	Period I: Arm 4: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
DRUG	Comparator: placebo	Period I: Arm 5: Pbo tablet once daily. 12 weeks of treatment.
DRUG	etoricoxib	Period II: Arm 1: etoricoxib 90 mg tablet once daily. 12 weeks of treatment.
DRUG	Comparator: diclofenac	Period II: Arm 2: diclofenac 75 mg tablet twice daily. 12 weeks of treatment.

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2005-12-12
• Last updated: 2022-02-09
• Results posted: 2009-07-07