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COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00113308
First received: June 7, 2005
Last updated: June 7, 2012
Last verified: May 2012
History of Changes

June 7, 2005
June 7, 2012
June 2005
September 2006   (final data collection date for primary outcome measure)
20% improvement in the number of tender/painful joints & swollen joints, 20% improvement in at least 3 of the following: patient's pain, patient's or physician's global impression of arthritis, functional disability, and c-reactive protein.
The % of subjects having at least a 20% improvement in the # of painful joints, # of swollen joints, patient's pain, patient's and physician's impression of arthritis, functional disability, and c-reactive protein.
Complete list of historical versions of study NCT00113308 on ClinicalTrials.gov Archive Site
Change in the individual components of ACR20 as listed above at each scheduled visit. Subjects discontinuing due to lack of efficacy, use of rescue medication, adverse events, safety measures (labs, ECG, vital signs) and health-related quality of life.
  • Change in components listed above at each scheduled visit.
  • Subjects discontinuing due to lack of efficacy,use of rescue medication, adverse events.
 
 
 
COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis
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

This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis.
 
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Arthritis, Rheumatoid
Drug: GW406381
Other Name: GW406381
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2208
September 2006
September 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   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
 
NCT00113308
CXA30009
No
GlaxoSmithKline
GlaxoSmithKline
 
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2012

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