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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
  Purpose

This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis.


Condition Intervention Phase
Arthritis, Rheumatoid
 Drug: GW406381
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 2208
Study Start Date: June 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW406381
    Other Name: GW406381
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00113308

  Show 287 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00113308     History of Changes
Other Study ID Numbers: CXA30009
Study First Received: June 7, 2005
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Rheumatoid Arthritis
COX-2 Inhibitor

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013