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Sponsored by: |
Wyeth |
---|---|
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00038922 |
To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis.
To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples.
Condition | Intervention | Phase |
---|---|---|
Ulcerative Colitis Inflammatory Bowel Disease |
Drug: rhIL-11 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Safety and Exploratory Pharmacogenomic Study of Orally Administered Recombinant Human Interleukin Eleven (rhIL-11) in Patients With Mild to Moderate Left-Sided Ulcerative Colitis |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 3067K5-114 |
Study First Received: | June 5, 2002 |
Last Updated: | May 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00038922 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Left-Sided Ulcerative Colitis |
Oprelvekin Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Gastroenteritis Intestinal Diseases Colitis |
Gastrointestinal Diseases Antineoplastic Agents Ulcer Colonic Diseases Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases |
Pharmacologic Actions Digestive System Diseases Pathologic Processes Oprelvekin Therapeutic Uses Gastroenteritis Colitis |