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CompletedNCT00366938Updated May 21, 2012

Efficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).

A Phase 3 interventional study of Lumiracoxib in Osteoarthritis, Knee, sponsored by Novartis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-21.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,464
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).

02

Conditions studied

  • Osteoarthritis, Knee

Keywords

  • Osteoarthritis, lumiracoxib, celecoxib, Cox-2
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 1,464 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis 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

Inclusion criteria

  • Primary osteoarthritis of knee (confirmed by American College of Rheumatology [ACR] criteria).
  • Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.

Exclusion criteria

Exclusion Criteria:

  • Evidence of active gastrointestinal ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.
  • Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).

Other protocol-defined inclusion/exclusion criteria may apply.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
1,464 participants

Interventions

  • DrugLumiracoxib
06

What researchers measure

Primary outcomes

  1. Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.

  2. Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13.

  3. Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13.

Secondary outcomes

  1. Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.

  2. Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.

  3. Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.

  4. Patient's health status using the Short Form-36 (SF-36), at week 13.

  5. Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.

07

Study locations

1 site
  • Novartis Pharmaceuticals Corporation
    E. Hanover, New Jersey 07936, United States
08

References and documents

Publications

  • Dougados M, Moore A, Yu S, Gitton X. Evaluation of the patient acceptable symptom state in a pooled analysis of two multicentre, randomised, double-blind, placebo-controlled studies evaluating lumiracoxib and celecoxib in patients with osteoarthritis. Arthritis Res Ther. 2007;9(1):R11. doi: 10.1186/ar2118. PubMed 17266764 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00366938
Lead sponsor
Novartis
First posted
Aug 22, 2006
Start date
Sep 2003
Primary completion
Mar 2004
Last update
May 21, 2012

Study contacts

Novartis Pharmaceuticals
study chair · Novartis
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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