Study Evaluating rhIL-11 in Active Crohn’s Disease

This study has been completed.

First Received: June 27, 2002 Last Updated: May 10, 2006 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00040521

Purpose

The purpose of this study is to assess the activity of multiple doses of oral rhIL-11 in patients with active Crohn’s disease (Crohn’s Disease Activity Index [CDAI] score from 220-400).

Condition	Intervention	Phase
Crohn Disease Inflammatory Bowel Disease	Drug: Recombinant Human Interleukin-11 (rhIL-11)	Phase II

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Oprelvekin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of Orally Administered Recombinant Human Interleukin-11 (rhIL-11) for the Treatment of Patients With Active Crohn’s Disease

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented, signed and dated informed consent to participate in this trial prior to any study related procedures being performed.
Men and women age 16 years and over.
Diagnosis of Crohn’s disease for at least 6 months that has been appropriately documented and confirmed by radiological studies, endoscopy (with histological examination preferred), or surgical pathology (Patients with a diagnosis of Crohn’s disease for less than 6 months may be included if the diagnosis is confirmed by a biopsy characteristic of Crohn’s disease)

Exclusion Criteria:

Use of the following medications within the specified time period prior to randomization:

Nonsteroidal anti-inflammatory drugs (NSAIDs; including Cyclooxygenase-2 [COX-2] inhibitors and >500 mg/day acetylsalicylic acid)
Codeine-containing compounds
Corticosteroid enemas

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040521

Locations

United States, Colorado

Arvada, Colorado, United States, 80002
United States, North Carolina

Chapel Hill, North Carolina, United States, 27599-7032

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

clinicaltrialinfo@wyeth.com

More Information

No publications provided

Study ID Numbers:	3067K5-208
Study First Received:	June 27, 2002
Last Updated:	May 10, 2006
ClinicalTrials.gov Identifier:	NCT00040521 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Crohn's Disease
Active Crohns Disease

Study placed in the following topic categories:

Crohn's Disease
Oprelvekin
Digestive System Diseases
Gastrointestinal Diseases
Ileitis
Enteritis

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases
Ileal Diseases

Additional relevant MeSH terms:

Ileitis
Gastrointestinal Diseases
Antineoplastic Agents
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases
Ileal Diseases

Pharmacologic Actions
Digestive System Diseases
Oprelvekin
Therapeutic Uses
Crohn Disease
Gastroenteritis

ClinicalTrials.gov processed this record on May 07, 2009