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Safety of Lumiracoxib in Patients With Osteoarthritis

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: March 18, 2008
Last Update Posted: March 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
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
Osteoarthritis Device: lumiracoxib Drug: rofecoxib Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00637949     History of Changes
Other Study ID Numbers: CCOX189A2307
First Submitted: March 11, 2008
First Posted: March 18, 2008
Last Update Posted: March 18, 2008
Last Verified: March 2008

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
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents