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Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

Primary Purpose

Ulcerative Colitis, Inflammatory Bowel Disease

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
rhIL-11
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Left-Sided, Ulcerative, Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 5, 2002
    Last Updated
    May 17, 2006
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00038922
    Brief Title
    Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2006
    Overall Recruitment Status
    Terminated
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ulcerative Colitis, Inflammatory Bowel Disease
    Keywords
    Left-Sided, Ulcerative, Colitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    rhIL-11

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor, MD
    Organizational Affiliation
    Wyeth is now a wholly owned subsidiary of Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

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