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Safety of Lumiracoxib in Patients With Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00637949
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : March 18, 2008
Sponsor:
Information provided by:
Novartis

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: lumiracoxib Drug: rofecoxib Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 309 participants
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
Study Start Date : December 2000
Actual Primary Completion Date : March 2001
Actual Study Completion Date : March 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Incidence of at least one of seven predefined gastrointestinal adverse events [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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


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 Posted: March 18, 2008    Key Record Dates
Last Update Posted: March 18, 2008
Last Verified: March 2008

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