NCT00170781

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

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

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

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

November 30, 2006

Status Verified

June 1, 2006

First QC Date

September 9, 2005

Last Update Submit

November 29, 2006

Conditions

Acute Gouty Arthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Interventions

LumiracoxibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis

Nuremberg, Germany

Location

For Site Information, contact Novartis Pharma AG

Basel, CH, 4002, Switzerland

Location

MeSH Terms

Conditions

PainArthritis

Interventions

lumiracoxib

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Novartis Pharma AG

    Sponsor GmbH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

June 1, 2005

Last Updated

November 30, 2006

Record last verified: 2006-06

Locations

CH(1)DE(1)