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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00113308




Registration number
NCT00113308
Ethics application status
Date submitted
7/06/2005
Date registered
8/06/2005
Date last updated
14/03/2017

Titles & IDs
Public title
COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis
Scientific title
A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg Administered Orally Once Daily, in Adults With Rheumatoid Arthritis
Secondary ID [1] 0 0
CXA30009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

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

Outcomes
Primary outcome [1] 0 0
Percentage of American College of Rheumatology (ACR)20 Responders at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Change from baseline to each scheduled visit in tender/painful joint count (68 joint panel)
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Change from baseline to each scheduled visit in swollen joint count (66 joint panel)
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
Change from baseline to each scheduled visit in patient's pain assessment (VAS)
Timepoint [3] 0 0
Baseline and Week 12
Secondary outcome [4] 0 0
Change from baseline to each scheduled visit in physician's global assessment of arthritis condition
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [5] 0 0
Change from baseline to each scheduled visit in patient's global assessment of arthritis condition
Timepoint [5] 0 0
Baseline and Week 12
Secondary outcome [6] 0 0
Change from baseline to each scheduled visit in functional disability index (HAQ)
Timepoint [6] 0 0
Baseline and Week 12
Secondary outcome [7] 0 0
Change between baseline and end of treatment (or early withdrawal) in the Short Form - McGill Pain Questionnaire (SF-MPQ)
Timepoint [7] 0 0
Baseline and Up to Week 12
Secondary outcome [8] 0 0
Change from baseline to each scheduled visit in C-reactive protein (CRP)
Timepoint [8] 0 0
Baseline and up to Week 12
Secondary outcome [9] 0 0
Number of participants withdrawing from the study due to lack of efficacy
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Number of participants who received supplementary analgesic therapy
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Timepoint [11] 0 0
Baseline and up to Week 12
Secondary outcome [12] 0 0
Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- heart rate (HR)
Timepoint [12] 0 0
Baseline and up to Week 12
Secondary outcome [13] 0 0
Changes from pretreatment to on treatment and post-treatment follow-up in weight
Timepoint [13] 0 0
Baseline and Week 12
Secondary outcome [14] 0 0
Number of participants with change in BMI of potential clinical concern
Timepoint [14] 0 0
Week 4, 4, 8, 12 and foloow up
Secondary outcome [15] 0 0
Number of participants with change from baseline of pedal oedema (including diuretic use)
Timepoint [15] 0 0
Baseline and up to Week 12
Secondary outcome [16] 0 0
Change from baseline in 12-lead electrocardiograms (ECGs)
Timepoint [16] 0 0
Baseline and up to Week 12
Secondary outcome [17] 0 0
Change from baseline in clinical chemistry parameters: Albumin
Timepoint [17] 0 0
Baseline and up to Week 12
Secondary outcome [18] 0 0
Change from baseline in clinical chemistry parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase
Timepoint [18] 0 0
Baseline and Up to Week 12
Secondary outcome [19] 0 0
Change from baseline in clinical chemistry parameters: Total Bilirubin
Timepoint [19] 0 0
Baseline and up to Week 12
Secondary outcome [20] 0 0
Change from baseline in clinical chemistry parameters: Carbon Dioxide content /Bicarbonate, Glucose, Potassium, Sodium
Timepoint [20] 0 0
Baseline and up to Week 12
Secondary outcome [21] 0 0
Change from baseline in clinical chemistry parameters: Creatinine
Timepoint [21] 0 0
Baseline and up to Week 12
Secondary outcome [22] 0 0
Change from baseline in haematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, White Blood Cell count
Timepoint [22] 0 0
Baseline and up to Week 12
Secondary outcome [23] 0 0
Change from baseline in haematology parameters: Hemoglobin
Timepoint [23] 0 0
Baseline and up to Week 12
Secondary outcome [24] 0 0
Change from baseline in haematology parameters: Mean Corpuscle volume
Timepoint [24] 0 0
Baseline and Up to Week 12
Secondary outcome [25] 0 0
Change from baseline in haematology parameters: Red Blood Cell count
Timepoint [25] 0 0
Baseline and up to Week 12
Secondary outcome [26] 0 0
Urinalysis assessment
Timepoint [26] 0 0
Up to Week 12
Secondary outcome [27] 0 0
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timepoint [27] 0 0
Upto Week 12
Secondary outcome [28] 0 0
Change in the Short Form-36 (SF-36v2) subscale scores between baseline and the end of treatment (or early withdrawal)
Timepoint [28] 0 0
Baseline and Week 12
Secondary outcome [29] 0 0
Change in the Short Form-36 (SF-36v2) Physical component summary score and mental component summary score between baseline and the end of treatment (or early withdrawal)
Timepoint [29] 0 0
Baseline and Week 12
Secondary outcome [30] 0 0
Psychometrically test and validate the amended Patient Satisfaction with Pain Medication questionnaire
Timepoint [30] 0 0
Week 12
Secondary outcome [31] 0 0
Change between baseline and end of treatment (or early withdrawal) in the EuroQoL Questionnaire -5 Dimensions (EQ-5D) utility score, using European population utility tariff
Timepoint [31] 0 0
Baseline and Week 12
Secondary outcome [32] 0 0
Change between baseline and end of treatment (or early withdrawal) in the fatigue/inertia factor of the Profile of Moods States Brief Form (POMS-B)
Timepoint [32] 0 0
Baseline and Week 12

Eligibility
Key inclusion criteria
Inclusion criteria:

* Rheumatoid arthritis (RA) for at least 12 months.
* Required a non-steroidal anti-inflammatory drug (NSAID) or COX-2 inhibitor for RA for at least 5 out of 7 days of each week for the 4 weeks prior to screening.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Any history of cardiovascular disease (e.g., heart attack, stroke, congestive heart failure, uncontrolled high blood pressure), documented peripheral arterial insufficiency and symptomatic, clinically significant claudication, or who have a history of peripheral arterial embolism.
* Have an active stomach ulcer or history of any stomach tear or bleeding.

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?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
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
1/06/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
2208
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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California
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Colorado
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United States of America
State/province [5] 0 0
Connecticut
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United States of America
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Florida
Country [7] 0 0
United States of America
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Georgia
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United States of America
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Idaho
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nevada
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New Hampshire
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New Jersey
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New York
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North Carolina
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Washington
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Wisconsin
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Argentina
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Córdova
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Argentina
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Santa Fe
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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Argentina
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Quilmes
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Lommel
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Mons
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Pleven
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Sofia
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Aalborg
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Campania
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Liguria
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Harstad
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Russian Federation
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Saratov
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Russian Federation
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St. Petersburg
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Tula
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Russian Federation
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Yaroslavl
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Durban
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Valencia
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Villajoyosa
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Ukraine
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Kharkiv
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Kyiv
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Ukraine
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Lviv
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United Kingdom
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Cornwall
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Hertfordshire
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Lancashire
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Merseyside
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United Kingdom
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Middlesex
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United Kingdom
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Northamptonshire

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00113308