Safety of Lumiracoxib in Patients With Osteoarthritis
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
1 other identifier
interventional
309
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2000
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2001
CompletedFirst Submitted
Initial submission to the registry
March 11, 2008
CompletedFirst Posted
Study publicly available on registry
March 18, 2008
CompletedMarch 18, 2008
March 1, 2008
3 months
March 11, 2008
March 17, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of at least one of seven predefined gastrointestinal adverse events
6 weeks
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Secondary osteoarthritis
- Active upper gastro intestinal tract ulceration
- Inflammatory joint disease
- Gout
- Clinically significant hepatic or renal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Related Publications (1)
Stricker K, Yu S, Krammer G. A 6-week, multicentre, randomised, double-blind, double-dummy, active-controlled, clinical safety study of lumiracoxib and rofecoxib in osteoarthritis patients. BMC Musculoskelet Disord. 2008 Sep 8;9:118. doi: 10.1186/1471-2474-9-118.
PMID: 18778469DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 11, 2008
First Posted
March 18, 2008
Study Start
December 1, 2000
Primary Completion
March 1, 2001
Study Completion
March 1, 2001
Last Updated
March 18, 2008
Record last verified: 2008-03