Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis
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
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2002
CompletedFirst Posted
Study publicly available on registry
June 7, 2002
CompletedMay 18, 2006
May 1, 2006
June 5, 2002
May 17, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Crohn's disease
- Ulcerative proctitis
- Ulcerative colitis extending beyond the splenic flexure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor, MD
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 5, 2002
First Posted
June 7, 2002
Last Updated
May 18, 2006
Record last verified: 2006-05