Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

Phase 1

Terminated

• Conditions: Ulcerative Colitis; Inflammatory Bowel Disease

• Registration Number: NCT00038922
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-06-05
• Study First Submitted QC: 2002-06-06
• Study First Posted: 2002-06-07
• Status Verified: 2006-05
• Last Update Submitted: 2006-05-17
• Last Update Posted: 2006-05-18

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified