Study Evaluating rhIL-11 in Active Crohn's Disease

Wyeth

Status and phase: Completed; Phase 2

Conditions: Inflammatory Bowel Disease; Crohn Disease

Treatments: Drug: Recombinant Human Interleukin-11 (rhIL-11)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00040521

3067K5-208

B2491021 (Other Identifier)

Details and patient eligibility

About

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).

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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