Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

This study has been terminated.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: June 5, 2002
Last updated: May 17, 2006
Last verified: May 2006

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.

Condition Intervention Phase
Ulcerative Colitis
Inflammatory Bowel Disease
Drug: rhIL-11
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Safety and Exploratory Pharmacogenomic Study of Orally Administered Recombinant Human Interleukin Eleven (rhIL-11) in Patients With Mild to Moderate Left-Sided Ulcerative Colitis

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00038922

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided Identifier: NCT00038922     History of Changes
Other Study ID Numbers: 3067K5-114
Study First Received: June 5, 2002
Last Updated: May 17, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Additional relevant MeSH terms:
Colitis, Ulcerative
Inflammatory Bowel Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 14, 2014