Study Evaluating rhIL-11 in Active Crohn's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2003-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Crohn Disease Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Recombinant Human Interleukin-11 (rhIL-11)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No