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Safety of Lumiracoxib in Patients With Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00637949
First received: March 11, 2008
Last updated: March 17, 2008
Last verified: March 2008
History of Changes
  Purpose

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
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:

MedlinePlus related topics: Edema Osteoarthritis
U.S. FDA Resources

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

  Eligibility

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

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

No publications provided by Novartis

Additional 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
Study First Received: March 11, 2008
Last Updated: March 17, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Osteoarthritis
lumiracoxib
rofecoxib
Cox-2
Osteoarthritis (primary osteoarthritis hip, hand, knee or spine (cervical or lumbar)

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Rofecoxib
Lumiracoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 18, 2013