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COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00113308
Recruitment Status : Completed
First Posted : June 8, 2005
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE June 7, 2005
First Posted Date  ICMJE June 8, 2005
Last Update Posted Date March 14, 2017
Study Start Date  ICMJE June 2005
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2017)
Percentage of American College of Rheumatology (ACR)20 Responders at Week 12 [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00113308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2017)
  • Change from baseline to each scheduled visit in tender/painful joint count (68 joint panel) [ Time Frame: Baseline and Week 12 ]
  • Change from baseline to each scheduled visit in swollen joint count (66 joint panel) [ Time Frame: Baseline and Week 12 ]
  • Change from baseline to each scheduled visit in patient's pain assessment (VAS) [ Time Frame: Baseline and Week 12 ]
  • Change from baseline to each scheduled visit in physician's global assessment of arthritis condition [ Time Frame: Baseline and Week 12 ]
  • Change from baseline to each scheduled visit in patient's global assessment of arthritis condition [ Time Frame: Baseline and Week 12 ]
  • Change from baseline to each scheduled visit in functional disability index (HAQ) [ Time Frame: Baseline and Week 12 ]
  • Change between baseline and end of treatment (or early withdrawal) in the Short Form - McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Baseline and Up to Week 12 ]
  • Change from baseline to each scheduled visit in C-reactive protein (CRP) [ Time Frame: Baseline and up to Week 12 ]
  • Number of participants withdrawing from the study due to lack of efficacy [ Time Frame: Week 12 ]
  • Number of participants who received supplementary analgesic therapy [ Time Frame: Week 12 ]
  • Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- systolic blood pressure (SBP) and diastolic blood pressure (DBP) [ Time Frame: Baseline and up to Week 12 ]
  • Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- heart rate (HR) [ Time Frame: Baseline and up to Week 12 ]
  • Changes from pretreatment to on treatment and post-treatment follow-up in weight [ Time Frame: Baseline and Week 12 ]
  • Number of participants with change in BMI of potential clinical concern [ Time Frame: Week 4, 4, 8, 12 and foloow up ]
  • Number of participants with change from baseline of pedal oedema (including diuretic use) [ Time Frame: Baseline and up to Week 12 ]
  • Change from baseline in 12-lead electrocardiograms (ECGs) [ Time Frame: Baseline and up to Week 12 ]
  • Change from baseline in clinical chemistry parameters: Albumin [ Time Frame: Baseline and up to Week 12 ]
  • Change from baseline in clinical chemistry parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase [ Time Frame: Baseline and Up to Week 12 ]
  • Change from baseline in clinical chemistry parameters: Total Bilirubin [ Time Frame: Baseline and up to Week 12 ]
  • Change from baseline in clinical chemistry parameters: Carbon Dioxide content /Bicarbonate, Glucose, Potassium, Sodium [ Time Frame: Baseline and up to Week 12 ]
  • Change from baseline in clinical chemistry parameters: Creatinine [ Time Frame: Baseline and up to Week 12 ]
  • Change from baseline in haematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, White Blood Cell count [ Time Frame: Baseline and up to Week 12 ]
  • Change from baseline in haematology parameters: Hemoglobin [ Time Frame: Baseline and up to Week 12 ]
  • Change from baseline in haematology parameters: Mean Corpuscle volume [ Time Frame: Baseline and Up to Week 12 ]
  • Change from baseline in haematology parameters: Red Blood Cell count [ Time Frame: Baseline and up to Week 12 ]
  • Urinalysis assessment [ Time Frame: Up to Week 12 ]
  • Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Upto Week 12 ]
  • Change in the Short Form-36 (SF-36v2) subscale scores between baseline and the end of treatment (or early withdrawal) [ Time Frame: Baseline and Week 12 ]
  • 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) [ Time Frame: Baseline and Week 12 ]
  • Psychometrically test and validate the amended Patient Satisfaction with Pain Medication questionnaire [ Time Frame: Week 12 ]
  • 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 [ Time Frame: Baseline and Week 12 ]
  • 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) [ Time Frame: Baseline and Week 12 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis
Official Title  ICMJE 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
Brief Summary This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE Drug: GW406381
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2005)
2208
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date September 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Belgium,   Bulgaria,   Canada,   Chile,   Costa Rica,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Ireland,   Italy,   Korea, Republic of,   Latvia,   Mexico,   Netherlands,   New Zealand,   Norway,   Peru,   Philippines,   Poland,   Puerto Rico,   Romania,   Russian Federation,   South Africa,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Estonia,   Lithuania,   Pakistan,   Slovakia,   Taiwan
 
Administrative Information
NCT Number  ICMJE NCT00113308
Other Study ID Numbers  ICMJE CXA30009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP