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

May 18, 2012 updated by: Novartis

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1684

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

August 18, 2006

First Submitted That Met QC Criteria

August 18, 2006

First Posted (Estimate)

August 22, 2006

Study Record Updates

Last Update Posted (Estimate)

May 21, 2012

Last Update Submitted That Met QC Criteria

May 18, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCOX189A2361

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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