Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

Wyeth

Status and phase: Terminated; Phase 1

Conditions: Inflammatory Bowel Disease; Ulcerative Colitis

Treatments: Drug: rhIL-11

Study type: Interventional

Funder types: Industry

Identifiers

NCT00038922

3067K5-114

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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