Back to resultsEfficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of Gout
Primary Purpose
Acute Gouty Arthritis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Lumiracoxib
Sponsored by
About this trial
This is an interventional treatment trial for Acute Gouty Arthritis focused on measuring Pain, acute gout, arthritis, cyclooxygenase-2 inhibitors, lumiracoxib, indomethacin
Eligibility Criteria
Inclusion Criteria: Ambulatory cooperative male or female patients of at least 18 years of age With an acute attack of gout in 4 joints or less, diagnosed clinically according to the ACR 1977 classification criteria and with an onset within the last 48 hours prior to evaluation. Where more than one joint is involved, the most affected joint should be identified, as the study joint, at baseline and followed throughout the study Who present at Baseline with an acute pain intensity of at least moderate. Exclusion Criteria: With an acute attack of gout before the last 48 hours prior to evaluation With polyarticular gout involving > 4 joints With rheumatoid arthritis, infectious arthritis, pseudo-gout or other acute inflammatory arthritides. Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Novartis
- For Site Information, contact Novartis Pharma AG
Outcomes
Primary Outcome Measures
Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose
Secondary Outcome Measures
Safety and tolerability profile
Pain intensity in the study joint over the entire treatment period
Patient's and Physician's global assessment of response to therapy
Physician's assessment of tenderness and swelling of study joint
C-reactive protein level
Proportion of patients who discontinued treatment because of a lack of efficacy
Usage of rescue medication
SF-36 and EQ-5D
Physician's assessment of erythema of study joint
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00170781
Brief Title
Efficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of Gout
Official Title
A 1-Week, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Parallel Trial Comparing Lumiracoxib (400 mg Once Daily) in Patients With Acute Flares of Gout, Using Indomethacin (50 mg Three Times a Day)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This study is designed to develop our understanding of the efficacy and safety of using lumiracoxib in the treatment of patients with acute gout. This is a multi-center, double-blind, randomized, parallel group study comparing a single daily dose of 400 mg lumiracoxib with the established dose of indomethacin 50 mg taken three times a day in terms of efficacy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gouty Arthritis
Keywords
Pain, acute gout, arthritis, cyclooxygenase-2 inhibitors, lumiracoxib, indomethacin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
234 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lumiracoxib
Primary Outcome Measure Information:
Title
Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose
Secondary Outcome Measure Information:
Title
Safety and tolerability profile
Title
Pain intensity in the study joint over the entire treatment period
Title
Patient's and Physician's global assessment of response to therapy
Title
Physician's assessment of tenderness and swelling of study joint
Title
C-reactive protein level
Title
Proportion of patients who discontinued treatment because of a lack of efficacy
Title
Usage of rescue medication
Title
SF-36 and EQ-5D
Title
Physician's assessment of erythema of study joint
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ambulatory cooperative male or female patients of at least 18 years of age
With an acute attack of gout in 4 joints or less, diagnosed clinically according to the ACR 1977 classification criteria and with an onset within the last 48 hours prior to evaluation. Where more than one joint is involved, the most affected joint should be identified, as the study joint, at baseline and followed throughout the study
Who present at Baseline with an acute pain intensity of at least moderate.
Exclusion Criteria:
With an acute attack of gout before the last 48 hours prior to evaluation
With polyarticular gout involving > 4 joints
With rheumatoid arthritis, infectious arthritis, pseudo-gout or other acute inflammatory arthritides.
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharma AG
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis
City
Nuernberg
Country
Germany
Facility Name
For Site Information, contact Novartis Pharma AG
City
Basel
State/Province
CH
ZIP/Postal Code
4002
Country
Switzerland
12. IPD Sharing Statement
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Efficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of Gout
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