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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00040521 |
The purpose of this study is to assess the activity of multiple doses of oral rhIL-11 in patients with active Crohn’s disease (Crohn’s Disease Activity Index [CDAI] score from 220-400).
Condition | Intervention | Phase |
---|---|---|
Crohn Disease Inflammatory Bowel Disease |
Drug: Recombinant Human Interleukin-11 (rhIL-11) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for the Treatment of Patients With Active Crohn’s Disease |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Use of the following medications within the specified time period prior to randomization:
United States, Colorado | |
Arvada, Colorado, United States, 80002 | |
United States, North Carolina | |
Chapel Hill, North Carolina, United States, 27599-7032 |
Study Director: | Medical Monitor | clinicaltrialinfo@wyeth.com |
Study ID Numbers: | 3067K5-208 |
Study First Received: | June 27, 2002 |
Last Updated: | May 10, 2006 |
ClinicalTrials.gov Identifier: | NCT00040521 |
Health Authority: | United States: Food and Drug Administration |
Crohn's Disease Active Crohns Disease |
Oprelvekin Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |