Study Evaluating rhIL-11 in Active Crohn's Disease

Phase 2

Completed

• Conditions: Crohn Disease; Inflammatory Bowel Disease

• Registration Number: NCT00040521
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2002-06-27
• Study First Submitted QC: 2002-06-27
• Study First Posted: 2002-06-28
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Status Verified: 2005-09
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified