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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00476034




Registration number
NCT00476034
Ethics application status
Date submitted
18/05/2007
Date registered
21/05/2007
Date last updated
21/05/2012

Titles & IDs
Public title
Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)
Scientific 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
Secondary ID [1] 0 0
CCOX189A2361E1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare lumiracoxib 100mg od to celecoxib 200mg od in treating osteoarthritis (OS) of the target knee with respect to:
Timepoint [1] 0 0
Primary outcome [2] 0 0
Overall OA pain intensity in the target knee on a 0-100 mm Visual Analog Scale (VAS) at 26 weeks.
Timepoint [2] 0 0
Primary outcome [3] 0 0
Patient's global assessment of disease activity on a 0-100mm VAS at 26 weeks.
Timepoint [3] 0 0
Primary outcome [4] 0 0
Patient's functional status using the WOMAC total score at 26 weeks
Timepoint [4] 0 0
Secondary outcome [1] 0 0
To assess the safety and tolerability profile of lumiracoxib as compared to celecoxib
Timepoint [1] 0 0
Secondary outcome [2] 0 0
To assess the efficacy of lumiracoxib as compared to celecoxib with respect to:
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Overall OA pain intensity on a 0-100 mm VAS by visit
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Patient's global assessment of disease activity by visit
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Physician's global assessment of disease activity by visit
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Patient's functional status using the WOMAC 3.1 LK sub-scale scores and total score by visit
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Usage of rescue medication
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Response to treatment according to OARSI criteria by visit
Timepoint [8] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
1312
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Malvern
Recruitment postcode(s) [1] 0 0
- Malvern
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Czech Republic
State/province [2] 0 0
Prague
Country [3] 0 0
Finland
State/province [3] 0 0
Turku
Country [4] 0 0
Germany
State/province [4] 0 0
Dresden
Country [5] 0 0
Hungary
State/province [5] 0 0
Budapest
Country [6] 0 0
Israel
State/province [6] 0 0
Haifa
Country [7] 0 0
Netherlands
State/province [7] 0 0
Lisse
Country [8] 0 0
New Zealand
State/province [8] 0 0
Rotorua
Country [9] 0 0
Poland
State/province [9] 0 0
Poznan
Country [10] 0 0
Slovakia
State/province [10] 0 0
Bratislava
Country [11] 0 0
South Africa
State/province [11] 0 0
Johannesburg
Country [12] 0 0
Spain
State/province [12] 0 0
Sevilla
Country [13] 0 0
Sweden
State/province [13] 0 0
Uppsala
Country [14] 0 0
Turkey
State/province [14] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00476034
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00476034