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 Evaluating rhIL-11 in Active Crohn's Disease

Sponsors

Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Source Wyeth is now a wholly owned subsidiary of Pfizer
Brief Summary

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).

Overall Status Completed
Start Date April 2002
Completion Date October 2003
Primary Completion Date October 2003
Phase Phase 2
Study Type Interventional
Condition
Intervention

Intervention type: Drug

Intervention name: Recombinant Human Interleukin-11 (rhIL-11)

Eligibility

Criteria:

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

Gender: All

Minimum age: 16 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Medical Monitor Study Director [email protected]
Location
facility
| Arvada, Colorado, 80002, United States
| Chapel Hill, North Carolina, 27599-7032, United States
Location Countries

United States

Verification Date

September 2005

Responsible Party

Responsible party type: Sponsor

Keywords
Condition Browse
Study Design Info

Allocation: Randomized

Primary purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov