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CompletedNCT00170781Updated Nov 30, 2006

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

A Phase 4 interventional study of Lumiracoxib in Acute Gouty Arthritis, sponsored by Novartis. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-11-30.

Sponsored by Novartis · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
234
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Acute Gouty Arthritis

Keywords

  • Pain, acute gout, arthritis, cyclooxygenase-2 inhibitors, lumiracoxib, indomethacin
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 234 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
234 participants

Interventions

  • DrugLumiracoxib
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Safety and tolerability profile

  2. Pain intensity in the study joint over the entire treatment period

  3. Patient's and Physician's global assessment of response to therapy

  4. Physician's assessment of tenderness and swelling of study joint

  5. C-reactive protein level

  6. Proportion of patients who discontinued treatment because of a lack of efficacy

  7. Usage of rescue medication

  8. SF-36 and EQ-5D

  9. Physician's assessment of erythema of study joint

07

Study locations

2 sites
  • Novartis
    Nuernberg, Germany
  • For Site Information, contact Novartis Pharma AG
    Basel, CH 4002, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00170781
Lead sponsor
Novartis
First posted
Sep 15, 2005
Start date
Jun 2005
Last update
Nov 30, 2006

Study contacts

Novartis Pharma AG
study chair · Sponsor GmbH
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2006. You cannot join it, but the record below documents what was studied.

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