Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nevada
Country [19] 0 0
United States of America
State/province [19] 0 0
New Hampshire
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oklahoma
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
South Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
United States of America
State/province [31] 0 0
Wisconsin
Country [32] 0 0
Argentina
State/province [32] 0 0
Córdova
Country [33] 0 0
Argentina
State/province [33] 0 0
Santa Fe
Country [34] 0 0
Argentina
State/province [34] 0 0
Ciudad Autónoma de Buenos Aires
Country [35] 0 0
Argentina
State/province [35] 0 0
Cordoba
Country [36] 0 0
Argentina
State/province [36] 0 0
Quilmes
Country [37] 0 0
Argentina
State/province [37] 0 0
San Juan
Country [38] 0 0
Argentina
State/province [38] 0 0
Tucuman
Country [39] 0 0
Austria
State/province [39] 0 0
Vienna
Country [40] 0 0
Belgium
State/province [40] 0 0
Antwerpen
Country [41] 0 0
Belgium
State/province [41] 0 0
Diepenbeek
Country [42] 0 0
Belgium
State/province [42] 0 0
Lommel
Country [43] 0 0
Belgium
State/province [43] 0 0
Mons
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Pleven
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Sofia
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Varna
Country [47] 0 0
Canada
State/province [47] 0 0
Alberta
Country [48] 0 0
Canada
State/province [48] 0 0
British Columbia
Country [49] 0 0
Canada
State/province [49] 0 0
Manitoba
Country [50] 0 0
Canada
State/province [50] 0 0
Newfoundland and Labrador
Country [51] 0 0
Canada
State/province [51] 0 0
Ontario
Country [52] 0 0
Canada
State/province [52] 0 0
Quebec
Country [53] 0 0
Canada
State/province [53] 0 0
Saskatchewan
Country [54] 0 0
Chile
State/province [54] 0 0
Región Metro De Santiago
Country [55] 0 0
Chile
State/province [55] 0 0
Valparaíso
Country [56] 0 0
Costa Rica
State/province [56] 0 0
San Jose
Country [57] 0 0
Denmark
State/province [57] 0 0
Aalborg
Country [58] 0 0
Denmark
State/province [58] 0 0
Ishoj
Country [59] 0 0
Denmark
State/province [59] 0 0
Odense C
Country [60] 0 0
Denmark
State/province [60] 0 0
Vejle
Country [61] 0 0
Finland
State/province [61] 0 0
Helsinki
Country [62] 0 0
Finland
State/province [62] 0 0
Hyvinkaa
Country [63] 0 0
Finland
State/province [63] 0 0
Kuopio
Country [64] 0 0
France
State/province [64] 0 0
Angers
Country [65] 0 0
France
State/province [65] 0 0
Cahors cedex 9
Country [66] 0 0
France
State/province [66] 0 0
Chilly Mazarin
Country [67] 0 0
France
State/province [67] 0 0
Corbeil Essonnes Cedex
Country [68] 0 0
France
State/province [68] 0 0
Grenoble cedex 09
Country [69] 0 0
France
State/province [69] 0 0
Lyon
Country [70] 0 0
France
State/province [70] 0 0
Paris cedex 12
Country [71] 0 0
France
State/province [71] 0 0
Toulouse
Country [72] 0 0
France
State/province [72] 0 0
Tours
Country [73] 0 0
Germany
State/province [73] 0 0
Baden-Wuerttemberg
Country [74] 0 0
Germany
State/province [74] 0 0
Bayern
Country [75] 0 0
Germany
State/province [75] 0 0
Hessen
Country [76] 0 0
Germany
State/province [76] 0 0
Mecklenburg-Vorpommern
Country [77] 0 0
Germany
State/province [77] 0 0
Niedersachsen
Country [78] 0 0
Germany
State/province [78] 0 0
Nordrhein-Westfalen
Country [79] 0 0
Germany
State/province [79] 0 0
Rheinland-Pfalz
Country [80] 0 0
Germany
State/province [80] 0 0
Saarland
Country [81] 0 0
Germany
State/province [81] 0 0
Sachsen-Anhalt
Country [82] 0 0
Germany
State/province [82] 0 0
Sachsen
Country [83] 0 0
Germany
State/province [83] 0 0
Schleswig-Holstein
Country [84] 0 0
Germany
State/province [84] 0 0
Berlin
Country [85] 0 0
Germany
State/province [85] 0 0
Hamburg
Country [86] 0 0
Greece
State/province [86] 0 0
Kavala
Country [87] 0 0
Greece
State/province [87] 0 0
Thessaloniki
Country [88] 0 0
Hungary
State/province [88] 0 0
Budapest
Country [89] 0 0
Hungary
State/province [89] 0 0
Gyor
Country [90] 0 0
India
State/province [90] 0 0
Bangalore
Country [91] 0 0
India
State/province [91] 0 0
Chennai
Country [92] 0 0
India
State/province [92] 0 0
Hyderabad, Andhra Pradesh
Country [93] 0 0
India
State/province [93] 0 0
Hyderabad
Country [94] 0 0
India
State/province [94] 0 0
New Delhi
Country [95] 0 0
India
State/province [95] 0 0
Pune.
Country [96] 0 0
Ireland
State/province [96] 0 0
Dublin
Country [97] 0 0
Ireland
State/province [97] 0 0
Waterford
Country [98] 0 0
Italy
State/province [98] 0 0
Abruzzo
Country [99] 0 0
Italy
State/province [99] 0 0
Campania
Country [100] 0 0
Italy
State/province [100] 0 0
Liguria
Country [101] 0 0
Italy
State/province [101] 0 0
Lombardia
Country [102] 0 0
Italy
State/province [102] 0 0
Toscana
Country [103] 0 0
Italy
State/province [103] 0 0
Umbria
Country [104] 0 0
Italy
State/province [104] 0 0
Veneto
Country [105] 0 0
Korea, Republic of
State/province [105] 0 0
Anyang-Si
Country [106] 0 0
Korea, Republic of
State/province [106] 0 0
Daegu
Country [107] 0 0
Korea, Republic of
State/province [107] 0 0
Seoul
Country [108] 0 0
Latvia
State/province [108] 0 0
Liepaja
Country [109] 0 0
Latvia
State/province [109] 0 0
Riga
Country [110] 0 0
Latvia
State/province [110] 0 0
Valmiera
Country [111] 0 0
Mexico
State/province [111] 0 0
Jalisco
Country [112] 0 0
Mexico
State/province [112] 0 0
Nuevo León
Country [113] 0 0
Mexico
State/province [113] 0 0
Mexico, D.F.
Country [114] 0 0
Mexico
State/province [114] 0 0
Mexico
Country [115] 0 0
Netherlands
State/province [115] 0 0
Den Haag
Country [116] 0 0
Netherlands
State/province [116] 0 0
Etten-leur
Country [117] 0 0
Netherlands
State/province [117] 0 0
Gouda
Country [118] 0 0
Netherlands
State/province [118] 0 0
Heerlen
Country [119] 0 0
Netherlands
State/province [119] 0 0
Nijmegen
Country [120] 0 0
Netherlands
State/province [120] 0 0
Zwolle
Country [121] 0 0
New Zealand
State/province [121] 0 0
Auckland
Country [122] 0 0
New Zealand
State/province [122] 0 0
Christchurch
Country [123] 0 0
New Zealand
State/province [123] 0 0
Lower Hutt
Country [124] 0 0
New Zealand
State/province [124] 0 0
Rotorua
Country [125] 0 0
Norway
State/province [125] 0 0
Harstad
Country [126] 0 0
Norway
State/province [126] 0 0
Levanger
Country [127] 0 0
Norway
State/province [127] 0 0
Lillehammer
Country [128] 0 0
Norway
State/province [128] 0 0
Skien
Country [129] 0 0
Norway
State/province [129] 0 0
Tønsberg
Country [130] 0 0
Peru
State/province [130] 0 0
Callao
Country [131] 0 0
Peru
State/province [131] 0 0
Lima
Country [132] 0 0
Philippines
State/province [132] 0 0
Manila
Country [133] 0 0
Poland
State/province [133] 0 0
Grudziadz
Country [134] 0 0
Poland
State/province [134] 0 0
Poznan
Country [135] 0 0
Poland
State/province [135] 0 0
Warszawa
Country [136] 0 0
Poland
State/province [136] 0 0
Wroclaw
Country [137] 0 0
Puerto Rico
State/province [137] 0 0
Caguas
Country [138] 0 0
Romania
State/province [138] 0 0
Brasov
Country [139] 0 0
Romania
State/province [139] 0 0
Bucharest
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Ekaterinburg
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Moscow
Country [142] 0 0
Russian Federation
State/province [142] 0 0
Ryazan
Country [143] 0 0
Russian Federation
State/province [143] 0 0
Sankt-Petersburg
Country [144] 0 0
Russian Federation
State/province [144] 0 0
Saratov
Country [145] 0 0
Russian Federation
State/province [145] 0 0
St. Petersburg
Country [146] 0 0
Russian Federation
State/province [146] 0 0
Tula
Country [147] 0 0
Russian Federation
State/province [147] 0 0
Yaroslavl
Country [148] 0 0
South Africa
State/province [148] 0 0
Eastern Cape
Country [149] 0 0
South Africa
State/province [149] 0 0
Gauteng
Country [150] 0 0
South Africa
State/province [150] 0 0
Cape Town
Country [151] 0 0
South Africa
State/province [151] 0 0
Durban
Country [152] 0 0
South Africa
State/province [152] 0 0
Erasmus Kloof, Pretoria
Country [153] 0 0
South Africa
State/province [153] 0 0
Kempton Park
Country [154] 0 0
South Africa
State/province [154] 0 0
Observatory
Country [155] 0 0
South Africa
State/province [155] 0 0
Pinetown
Country [156] 0 0
Spain
State/province [156] 0 0
Baracaldo/Vizcaya
Country [157] 0 0
Spain
State/province [157] 0 0
Barcelona
Country [158] 0 0
Spain
State/province [158] 0 0
Cordoba
Country [159] 0 0
Spain
State/province [159] 0 0
Granada
Country [160] 0 0
Spain
State/province [160] 0 0
Guadalajara
Country [161] 0 0
Spain
State/province [161] 0 0
La Coruña
Country [162] 0 0
Spain
State/province [162] 0 0
Mérida (Badajoz)
Country [163] 0 0
Spain
State/province [163] 0 0
Oviedo
Country [164] 0 0
Spain
State/province [164] 0 0
Pamplona
Country [165] 0 0
Spain
State/province [165] 0 0
San Sebastián
Country [166] 0 0
Spain
State/province [166] 0 0
Santiago de Compostela
Country [167] 0 0
Spain
State/province [167] 0 0
Sevilla
Country [168] 0 0
Spain
State/province [168] 0 0
Valencia
Country [169] 0 0
Spain
State/province [169] 0 0
Villajoyosa
Country [170] 0 0
Ukraine
State/province [170] 0 0
Kharkiv
Country [171] 0 0
Ukraine
State/province [171] 0 0
Kiev
Country [172] 0 0
Ukraine
State/province [172] 0 0
Kyiv
Country [173] 0 0
Ukraine
State/province [173] 0 0
Lviv
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Cornwall
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Hertfordshire
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Lancashire
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Merseyside
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Middlesex
Country [179] 0 0
United Kingdom
State/province [179] 0 0
Northamptonshire

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis.
Trial website
https://clinicaltrials.gov/study/NCT00113308
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00113308