Study Evaluating rhIL-11 in Active Crohn's Disease

Completed · Phase 2

Conditions studied: Crohn Disease, Inflammatory Bowel Disease

In brief

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).

Key facts

Study ID

NCT00040521

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

Starts

2002-04-01

Expected to finish

2003-10-01

Last updated by the study team

2013-02-08

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Arvada, Colorado, United States
• Study site — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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