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Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00615199 |
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo (inactive drug).
Condition | Intervention | Phase |
---|---|---|
Crohn's Disease |
Drug: CP-690,550 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Investigate The Safety And Efficacy Of CP-690,550 In Subjects With Moderate To Severe Crohn's Disease. |
Estimated Enrollment: | 150 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1mg BD: Placebo Comparator |
Drug: CP-690,550
administration via oral route twice daily
|
5mg BD: Placebo Comparator |
Drug: CP-690,550
administration via oral route twice daily
|
15mg BD: Placebo Comparator |
Drug: CP-690,550
administration via oral route twice daily
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3921043 |
Study First Received: | January 14, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00615199 |
Health Authority: | United States: Food and Drug Administration |
Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |