Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Ulcerative Colitis Inflammatory Bowel Disease

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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rhIL-11

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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3067K5-114

Identifier Type: -

Identifier Source: org_study_id