Study Evaluating ERB-041 in Active Crohn's Disease

Phase 1

Completed

• Conditions: Crohn's Disease

• Registration Number: NCT00245947
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

Evaluate the response of inflammatory serum markers to oral ERB-041 in subjects with inflammation associated with active Crohn's disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Study First Submitted: 2005-10-26
• Study First Submitted QC: 2005-10-26
• Study First Posted: 2005-10-28
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-09
• Last Update Posted: 2009-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Men and women, minimum 18 years of age with a diagnosis of Crohn's disease greater than 3 months,
• Eligible subjects must have adequate hematologic, renal, and hepatic function.

Other inclusions apply

Exclusion Criteria

• Use of the following medications within the specified time period before randomization is prohibited:

Within 48 hours before randomization

• Nonsteroidal antiinflammatory drugs (NSAIDs) Within 2 weeks before randomization
• Herbal supplements (except for a daily multivitamin/mineral supplement not containing herbal components).

Other exclusions applies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Inflammatory serum markers
Pharmacogenomics
Safety

Secondary Outcome Measures

Name	Time	Method
Crohn's Disease Activity Index (CDAI) scores.
Cell surface markers
Fecal markers