NCT00170872

Brief Summary

This study tested the safety, tolerability and efficacy of lumiracoxib - a COX-2 inhibitor- in patients with primary knee osteoarthritis or rheumatoid arthritis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P25-P50 for phase_3

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

November 1, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
2 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

May 21, 2012

Status Verified

May 1, 2012

Enrollment Period

8 months

First QC Date

September 9, 2005

Last Update Submit

May 18, 2012

Conditions

OsteoarthritisRheumatoid Arthritis

Keywords

OsteoarthritisRheumatoid ArthritisCox-2lumiracoxib

Outcome Measures

Primary Outcomes (1)

  • Assess safety and tolerability profile of lumiracoxib in comparison to baseline

Secondary Outcomes (3)

  • Demonstrate that lumiracoxib 200mg o.d. is effective in treating OA and pain due to RA with respect to overall OA/ RA pain intensity on a 0-100 mm Visual Analog Scale (VAS) after 6 weeks of treatment in comparison to baseline

  • Assess efficacy of lumiracoxib compared to baseline with respect to a) overall OA/ RA pain intensity b) patient's and physician's global assessment of disease activity c) patient functional status

  • Use of rescue medication

Interventions

LumiracoxibDRUG

Eligibility Criteria

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

You may qualify if:

  • Requirement of regular NSAID therapy
  • With primary osteoarthritis of the target knee (by ACR Criteria) or with a diagnosis of rheumatoid arthritis (by ACR Criteria)

You may not qualify if:

  • Evidence of active ulceration of the UGI tract within 6 months prior to the screening visit or history of active bleeding of the UGI tract within the previous 5 years. As well as with pyloric or duodenal obstruction or with history of gastrointestinal parasites.
  • History of cardiac and cerebral thrombotic/ischemic diseases and/or events
  • Patients taking additional NSAIDs (including COX-2 inhibitors) during the course of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

OsteoarthritisArthritis, Rheumatoid

Interventions

lumiracoxib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Novartis Pharma AG

    Sponsor GmbH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

November 1, 2004

Primary Completion

July 1, 2005

Last Updated

May 21, 2012

Record last verified: 2012-05