Safety of Lumiracoxib in Patients With Osteoarthritis

Novartis

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Drug: rofecoxib; Device: lumiracoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00637949

CCOX189A2307

Details and patient eligibility

About

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

Enrollment: 309 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

309 participants in 2 patient groups

1

Experimental group

Treatment:

Device: lumiracoxib

2

Active Comparator group

Treatment:

Drug: rofecoxib