Study Evaluating rhIL-11 in Active Crohn's Disease
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ClinicalTrials.gov Identifier: NCT00040521 |
Recruitment Status
:
Completed
First Posted
: June 28, 2002
Last Update Posted
: February 8, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn Disease Inflammatory Bowel Disease | Drug: Recombinant Human Interleukin-11 (rhIL-11) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Masking: | Double |
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 |
Study Start Date : | April 2002 |
Actual Primary Completion Date : | October 2003 |
Actual Study Completion Date : | October 2003 |


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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00040521
United States, Colorado | |
Arvada, Colorado, United States, 80002 | |
United States, North Carolina | |
Chapel Hill, North Carolina, United States, 27599-7032 |
Study Director: | Medical Monitor | clinicaltrialinfo@wyeth.com |
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 ( Other Identifier: Pfizer ) |
First Posted: | June 28, 2002 Key Record Dates |
Last Update Posted: | February 8, 2013 |
Last Verified: | September 2005 |
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 Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Intestinal Diseases Oprelvekin Antineoplastic Agents |