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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00367315
First received: August 18, 2006
Last updated: May 18, 2012
Last verified: May 2012
History of Changes

August 18, 2006
May 18, 2012
September 2003
February 2004   (final data collection date for primary outcome measure)
  • Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 13 weeks.
  • Patient's global assessment of disease activity on a 0-100 mm VAS at 13 weeks.
  • Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score at 13 weeks.
Same as current
Complete list of historical versions of study NCT00367315 on ClinicalTrials.gov Archive Site
  • • Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
  • Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
  • Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
  • Patient's health status using the Short Form-36 (SF-36), at week 13.
  • Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
  • • Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
  • Patient’s global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
  • Patient’s functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
  • Patient’s health status using the Short Form-36 (SF-36), at week 13.
  • Physician’s global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
Not Provided
Not Provided
 
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)
A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator

This study will evaluate the efficacy and safety of using lumiracoxib in the treatment of patients with knee osteoarthritis (OA)
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Knee Osteoarthritis
Drug: Lumiracoxib
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1684
Not Provided
February 2004   (final data collection date for primary outcome measure)

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:

  • Evidence of active peptic 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
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany,   Switzerland
 
NCT00367315
CCOX189A2361
Not Provided
Novartis
Novartis
Not Provided
Study Chair: Novartis Pharmaceuticals Novartis
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP