Safety of Lumiracoxib in Patients With Osteoarthritis

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Device: lumiracoxib; Drug: rofecoxib

• Registration Number: NCT00637949
• Lead Sponsor: Novartis

Brief Summary

This safety study evaluated the incidence of gastrointestinal adverse events and edema in patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator

Detailed Description

Not available

Study Timeline

• Study Start: 2000-12
• Primary Completion: 2001-03
• Study Completion: 2001-03
• Status Verified: 2008-03
• Study First Submitted: 2008-03-11
• Study First Submitted QC: 2008-03-17
• Last Update Submitted: 2008-03-17
• Study First Posted: 2008-03-18
• Last Update Posted: 2008-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

Inclusion Criteria

• Age >=50 years old
• Primary osteoarthritis in hip, hand, knee or spine for at least 3 month
• Pain in the target joint of moderate intensity
• Written informed consent

Exclusion Criteria

• Secondary osteoarthritis
• Active upper gastro intestinal tract ulceration
• Inflammatory joint disease
• Gout
• Clinically significant hepatic or renal disease

Other in and exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	lumiracoxib	-
2	rofecoxib	-

Primary Outcome Measures

Name	Time	Method
Incidence of at least one of seven predefined gastrointestinal adverse events	6 weeks