NCT00367315

Brief Summary

This study will evaluate the efficacy and safety of using lumiracoxib in the treatment of patients with knee osteoarthritis (OA)

Trial Health

85
On Track

Trial Health Score

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

Enrollment
1,684

participants targeted

Target at P75+ for phase_3 knee-osteoarthritis

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2006

Completed
Last Updated

May 21, 2012

Status Verified

May 1, 2012

Enrollment Period

5 months

First QC Date

August 18, 2006

Last Update Submit

May 18, 2012

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis, lumiracoxib, celecoxib, cyclooxygenase-2 inhibitors

Outcome Measures

Primary Outcomes (3)

  • 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.

Secondary Outcomes (5)

  • • 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.

Interventions

LumiracoxibDRUG

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis

Nuremberg, Germany

Location

Novartis

Basel, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 17266764DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

lumiracoxib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2006

First Posted

August 22, 2006

Study Start

September 1, 2003

Primary Completion

February 1, 2004

Last Updated

May 21, 2012

Record last verified: 2012-05

Locations

DE(1)CH(1)