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Study Evaluating rhIL-11 in Active Crohn's Disease

Primary Purpose

Crohn Disease, Inflammatory Bowel Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Recombinant Human Interleukin-11 (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 Crohn Disease focused on measuring Crohn's Disease, Active Crohns Disease

Eligibility Criteria

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

Inclusion Criteria: Documented, signed and dated informed consent to participate in this trial prior to any study related procedures being performed. Men and women age 16 years and over. Diagnosis of Crohn's disease for at least 6 months that has been appropriately documented and confirmed by radiological studies, endoscopy (with histological examination preferred), or surgical pathology (Patients with a diagnosis of Crohn's disease for less than 6 months may be included if the diagnosis is confirmed by a biopsy characteristic of Crohn's disease) Exclusion Criteria: Use of the following medications within the specified time period prior to randomization: Nonsteroidal anti-inflammatory drugs (NSAIDs; including Cyclooxygenase-2 [COX-2] inhibitors and >500 mg/day acetylsalicylic acid) Codeine-containing compounds Corticosteroid enemas

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 27, 2002
Last Updated
February 7, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00040521
Brief Title
Study Evaluating rhIL-11 in Active Crohn's Disease
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for the Treatment of Patients With Active Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the activity of multiple doses of oral rhIL-11 in patients with active Crohn's disease (Crohn's Disease Activity Index [CDAI] score from 220-400).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Inflammatory Bowel Disease
Keywords
Crohn's Disease, Active Crohns Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Recombinant Human Interleukin-11 (rhIL-11)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented, signed and dated informed consent to participate in this trial prior to any study related procedures being performed. Men and women age 16 years and over. Diagnosis of Crohn's disease for at least 6 months that has been appropriately documented and confirmed by radiological studies, endoscopy (with histological examination preferred), or surgical pathology (Patients with a diagnosis of Crohn's disease for less than 6 months may be included if the diagnosis is confirmed by a biopsy characteristic of Crohn's disease) Exclusion Criteria: Use of the following medications within the specified time period prior to randomization: Nonsteroidal anti-inflammatory drugs (NSAIDs; including Cyclooxygenase-2 [COX-2] inhibitors and >500 mg/day acetylsalicylic acid) Codeine-containing compounds Corticosteroid enemas
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
clinicaltrialinfo@wyeth.com
Official's Role
Study Director
Facility Information:
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80002
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7032
Country
United States

12. IPD Sharing Statement

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Study Evaluating rhIL-11 in Active Crohn's Disease

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