Crohn Disease Clinical Trial
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
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).
Status | Completed |
Enrollment | 0 |
Est. completion date | October 2003 |
Est. primary completion date | October 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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 |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Wyeth is now a wholly owned subsidiary of Pfizer |
United States,
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