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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lumiracoxib
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, lumiracoxib, celecoxib, Cox-2, knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Any patient who completed the core study 2361 may enter the extension trial upon signing informed consent. A patient is defined as completing if he/she completed the core study 2361 up to and including Visit 6 (week 13) without a major protocol violation.

Exclusion Criteria:

  • Those patients for whom continued treatment in the extension study is not considered appropriate by the treating physician
  • Those patients who were non-compliant or who demonstrated a major protocol violation in the core study.

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Outcomes

Primary Outcome Measures

To compare lumiracoxib 100mg od to celecoxib 200mg od in treating osteoarthritis (OS) of the target knee with respect to:
Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 26 weeks.
Patient's global assessment of disease activity on a 0-100mm VAS at 26 weeks.
Patient's functional status using the WOMAC total score at 26 weeks

Secondary Outcome Measures

To assess the safety and tolerability profile of lumiracoxib as compared to celecoxib
To assess the efficacy of lumiracoxib as compared to celecoxib with respect to:
Overall OA pain intensity on a 0-100 mm VAS by visit
Patient's global assessment of disease activity by visit
Physician's global assessment of disease activity by visit
Patient's functional status using the WOMAC 3.1 LK sub-scale scores and total score by visit
Usage of rescue medication
Response to treatment according to OARSI criteria by visit

Full Information

First Posted
May 18, 2007
Last Updated
May 18, 2012
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00476034
Brief Title
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)
Official Title
A 39-week, Double-blind, Active-controlled Extension to CCOX189A2361, 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief Summary
This 39-week, active controlled, study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2361 study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, lumiracoxib, celecoxib, Cox-2, knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1312 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lumiracoxib
Primary Outcome Measure Information:
Title
To compare lumiracoxib 100mg od to celecoxib 200mg od in treating osteoarthritis (OS) of the target knee with respect to:
Title
Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 26 weeks.
Title
Patient's global assessment of disease activity on a 0-100mm VAS at 26 weeks.
Title
Patient's functional status using the WOMAC total score at 26 weeks
Secondary Outcome Measure Information:
Title
To assess the safety and tolerability profile of lumiracoxib as compared to celecoxib
Title
To assess the efficacy of lumiracoxib as compared to celecoxib with respect to:
Title
Overall OA pain intensity on a 0-100 mm VAS by visit
Title
Patient's global assessment of disease activity by visit
Title
Physician's global assessment of disease activity by visit
Title
Patient's functional status using the WOMAC 3.1 LK sub-scale scores and total score by visit
Title
Usage of rescue medication
Title
Response to treatment according to OARSI criteria by visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Any patient who completed the core study 2361 may enter the extension trial upon signing informed consent. A patient is defined as completing if he/she completed the core study 2361 up to and including Visit 6 (week 13) without a major protocol violation. Exclusion Criteria: Those patients for whom continued treatment in the extension study is not considered appropriate by the treating physician Those patients who were non-compliant or who demonstrated a major protocol violation in the core study. Other protocol-defined inclusion/exclusion criteria may apply
Facility Information:
Facility Name
Novartis Investigative Site
City
Malvern
Country
Australia
Facility Name
Novartis Investigative Site
City
Vienna
Country
Austria
Facility Name
Novartis Investigative Site
City
Prague
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Turku
Country
Finland
Facility Name
Novartis Investigative Site
City
Dresden
Country
Germany
Facility Name
Novartis Investigative Site
City
Budapest
Country
Hungary
Facility Name
Novartis Investigative Site
City
Haifa
Country
Israel
Facility Name
Novartis Investigative Site
City
Lisse
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Rotorua
Country
New Zealand
Facility Name
Novartis Investigative Site
City
Poznan
Country
Poland
Facility Name
Novartis Investigative Site
City
Bratislava
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Johannesburg
Country
South Africa
Facility Name
Novartis Investigative Site
City
Sevilla
Country
Spain
Facility Name
Novartis Investigative Site
City
Uppsala
Country
Sweden
Facility Name
Novartis Investigative Site
City
Izmir
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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