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Efficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of Gout

NCT ID: NCT00170781

Last Updated: 2006-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Acute Gouty Arthritis

Keywords

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Pain, acute gout, arthritis, cyclooxygenase-2 inhibitors, lumiracoxib, indomethacin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lumiracoxib

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis Pharma AG

Role: STUDY_CHAIR

Sponsor GmbH

Locations

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Novartis

Nuremberg, , Germany

Site Status

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Basel, CH, Switzerland

Site Status

Countries

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Germany Switzerland

Other Identifiers

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CCOX189A2426

Identifier Type: -

Identifier Source: org_study_id