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

Overview

No summary available.

Registry

who.int

Start Date

May 16, 2006

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Subject is a male or female outpatient, at least 18 years of age.
•A female is eligible to enter and participate in the study if she is of:
•a.Non\-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre\-menarchal or post\-menopausal); or,
•b.Childbearing potential, has a negative pregnancy test and is not lactating at the Screening Visit and Baseline Visit, and agrees to satisfying one of the requirements listed Appendix 3: Acceptable Methods of Contraception.
•2\.Subject is able and willing to give written informed consent.
•3\.Subject is able to read, comprehend and record information required in the protocol, e.g., complete assessments using an electronic device.
•4\.Onset of RA at \>16 years of age and symptom duration for \>12 months.
•5\.Diagnosis of RA as defined by the American Rheumatism Association (ARA) 1987 criteria..
•6\.ARA Functional Class I, II or III.
•7\.Required a NSAID or COX\-2 inhibitor for the treatment of their RA for at least 5 out of 7 days of each week for the 4 weeks prior to screen.

•1\.Known history of hypersensitivity or intolerance to NSAIDs, aspirin, COX\-2 inhibitors, unless subject has subsequently taken at least two separate NSAIDs/COX 2 inhibitors for at least one month without reaction. Intolerance of paracetamol acetominophen. History of aspirin\-sensitive asthma or nasal polyps.
•2\.Any clinical or biological abnormality found at screen (other than those related to the disease under investigation), which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study.
•3\.History of gastroduodenal perforations and/or obstructions.
•4\.History of any gastric or duodenal surgery.
•5\.Active gastrointestinal ulceration of the upper GI tract within the previous 6 months, bleeding of the upper GI tract within the previous year (including hematemesis).
•6\.History of lower GI bleeding (excluding hemorrhoids) within the past year.
•7\.History of inflammatory bowel disease.
•8\.Use of proton pump inhibitors at any dose for any period longer than 4 consecutive days during the month prior to study start or during the study unless the subject has a history of GI ulceration (\= 6 months prior to study start).
•9\.Use of sucralfate and misoprostol
•10\.Use of potent CYP3A4 inhibitors i.e., ritonavir, ketoconazole, itraconazole, saquinavir, nelfinavir, troleandomycin, azithromycin and erythromycin. Other CYP3A4 inhibitors are permitted.