Study Evaluating ERB-041 in Active Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Design, Exploratory Pharmacogenomic, Safety and Activity Study of Orally Administered ERB-041 in Subjects With Inflammation Associated With Active Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245947
• Other study ID #: 3142A3-102
• Status: Completed
• Phase: Phase 1
• First received: October 26, 2005
• Last updated: September 9, 2009
• Start date: April 2004
• Est. completion date: April 2005

Study information

• Verified date: September 2009
• 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• ERB-041

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory serum markers
Primary	Pharmacogenomics
Primary	Safety
Secondary	Crohn's Disease Activity Index (CDAI) scores.
Secondary	Cell surface markers
Secondary	Fecal markers