Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis
NCT00038922
ABOUT THIS STUDY
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- Documented, signed informed consent to participate in this study
- Age greater than or equal to 18 years
- Documented diagnosis of ulcerative colitis by standard clinical criteria, including endoscopy (either flexible sigmoidoscopy or colonoscopy, sufficient to define the proximal limit of disease) with biopsy
- Crohn's disease
- Ulcerative proctitis
- Ulcerative colitis extending beyond the splenic flexure
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: rhIL-11 | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00038922 | |||
Other Study ID Numbers ICMJE | 3067K5-114 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | May 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |