Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

This study has been terminated.

First Received: June 5, 2002 Last Updated: May 17, 2006 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00038922

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 I

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Ulcerative Colitis

Drug Information available for: Oprelvekin

Study Type:	Interventional
Study Design:	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

Eligibility

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038922

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

No publications provided

Study ID Numbers:	3067K5-114
Study First Received:	June 5, 2002
Last Updated:	May 17, 2006
ClinicalTrials.gov Identifier:	NCT00038922 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Left-Sided
Ulcerative
Colitis

Study placed in the following topic categories:

Oprelvekin
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases

Inflammatory Bowel Diseases
Colitis, Ulcerative
Gastroenteritis
Intestinal Diseases
Colitis

Additional relevant MeSH terms:

Gastrointestinal Diseases
Antineoplastic Agents
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases

Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Oprelvekin
Therapeutic Uses
Gastroenteritis
Colitis

ClinicalTrials.gov processed this record on May 07, 2009