Study Evaluating ERB-041 in Active Crohn's Disease

NCT ID: NCT00245947

Last Updated: 2009-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2005-04-30

Brief Summary

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

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

ERB-041

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

3142A3-102

Identifier Type: -

Identifier Source: org_study_id