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NCT00038922 Clinical Trial

Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00038922
Other study ID # 3067K5-114
Secondary ID
Status Terminated
Phase Phase 1
First received June 5, 2002
Last updated May 17, 2006

Study information
Verified date May 2006
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Crohn's disease

- Ulcerative proctitis

- Ulcerative colitis extending beyond the splenic flexure

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• rhIL-11

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer
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