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Study Evaluating rhIL-11 in Active Crohn's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00040521
First received: June 27, 2002
Last updated: February 7, 2013
Last verified: September 2005
History of Changes
  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 2

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:

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:

Study Start Date: April 2002
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
  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

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00040521     History of Changes
Other Study ID Numbers: 3067K5-208, B2491021
Study First Received: June 27, 2002
Last Updated: February 7, 2013
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 May 19, 2013