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Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00038922
First received: June 5, 2002
Last updated: May 17, 2006
Last verified: May 2006
History of Changes
  Purpose

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:

Drug Information available for: Oprelvekin
U.S. FDA Resources

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00038922

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

No publications provided

ClinicalTrials.gov 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:
Left-Sided
Ulcerative
Colitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Pathologic Processes
Oprelvekin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013