Study Evaluating rhIL-11 in Active Crohn’s Disease

This study has been completed.

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

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:	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 is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor

clinicaltrialinfo@wyeth.com

More Information

No publications provided

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

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

Crohn's Disease
Active Crohns Disease

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases

Digestive System Diseases
Oprelvekin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012