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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00040521
Other study ID # 3067K5-208
Secondary ID B2491021
Status Completed
Phase Phase 2
First received June 27, 2002
Last updated February 7, 2013
Start date April 2002
Est. completion date October 2003

Study information

Verified date September 2005
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

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


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

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