Official Title: “A 6-Week Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Parallel Group Clinical Saftey Study to Evaluate Incidence of Predefined Gastrointestinal Adverse Events and Peripheral Edema in Subjects With Primary Osteoarthritis Treated With COX189 400 mg o-do Using Rofecoxib 25 mg o.d. as a Comparator”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study

Study Primary Completion Date: March 2001

Intervention(s) in this Clinical Trial

• Device: lumiracoxib
  • 400 mg once daily, oral over 6 weeks
• Drug: rofecoxib
  • 25 mg, oral, daily over 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Incidence of at least one of seven predefined gastrointestinal adverse events
  • Time Frame: 6 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00637949

Study ID Number: CCOX189A2307

ClinicalTrials.gov Identifier: NCT00637949

Health Authority: United States: Food and Drug Administration