Study Evaluating rhIL-11 in Active Crohn's Disease

Crohn Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00040521
• Other study ID #: 3067K5-208
• Secondary ID: B2491021
• Status: Completed
• Phase: Phase 2
• First received: June 27, 2002
• Last updated: February 7, 2013
• Start date: April 2002
• Est. completion date: October 2003

Study information

• Verified date: September 2005
• 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2003
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Intervention

Drug:
• Recombinant Human Interleukin-11 (rhIL-11)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States,