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Safety of Lumiracoxib in Patients With Osteoarthritis

This study has been completed.
Information provided by:
Novartis Identifier:
First received: March 11, 2008
Last updated: March 17, 2008
Last verified: March 2008

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

Condition Intervention Phase
Device: lumiracoxib
Drug: rofecoxib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Incidence of at least one of seven predefined gastrointestinal adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 309
Study Start Date: December 2000
Study Completion Date: March 2001
Primary Completion Date: March 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: lumiracoxib
400 mg once daily, oral over 6 weeks
Other Name: Prexige
Active Comparator: 2 Drug: rofecoxib
25 mg, oral, daily over 6 weeks
Other Name: Vioxx


Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Identifier: NCT00637949     History of Changes
Other Study ID Numbers: CCOX189A2307
Study First Received: March 11, 2008
Last Updated: March 17, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Osteoarthritis (primary osteoarthritis hip, hand, knee or spine (cervical or lumbar)

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 24, 2014