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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476034
• Other study ID #: CCOX189A2361E1
• Status: Completed
• Phase: Phase 3
• First received: May 18, 2007
• Last updated: May 18, 2012
• Start date: December 2003

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesAustria: Federal Agency for Safety in Health CareAustralia: Department of Health and Ageing Therapeutic Goods AdministrationCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyHungary: National Institute of PharmacyIsrael: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)New Zealand: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSlovakia: State Institute for Drug ControlSouth Africa: Department of HealthSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1312
• Est. primary completion date: November 2004
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• lumiracoxib

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Malvern
Austria	Novartis Investigative Site	Vienna
Czech Republic	Novartis Investigative Site	Prague
Finland	Novartis Investigative Site	Turku
Germany	Novartis Investigative Site	Dresden
Hungary	Novartis Investigative Site	Budapest
Israel	Novartis Investigative Site	Haifa
Netherlands	Novartis Investigative Site	Lisse
New Zealand	Novartis Investigative Site	Rotorua
Poland	Novartis Investigative Site	Poznan
Slovakia	Novartis Investigative Site	Bratislava
South Africa	Novartis Investigative Site	Johannesburg
Spain	Novartis Investigative Site	Sevilla
Sweden	Novartis Investigative Site	Uppsala
Turkey	Novartis Investigative Site	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Australia,  Austria,  Czech Republic,  Finland,  Germany,  Hungary,  Israel,  Netherlands,  New Zealand,  Poland,  Slovakia,  South Africa,  Spain,  Sweden,  Turkey, 

Outcome

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