Back to resultsStudy Evaluating ERB-041 in Active Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ERB-041
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, Inflammation
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
Sites / Locations
Outcomes
Primary Outcome Measures
Inflammatory serum markers
Pharmacogenomics
Safety
Secondary Outcome Measures
Crohn's Disease Activity Index (CDAI) scores.
Cell surface markers
Fecal markers
Full Information
NCT ID
NCT00245947
First Posted
October 26, 2005
Last Updated
September 9, 2009
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00245947
Brief Title
Study Evaluating ERB-041 in Active Crohn's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
Evaluate the response of inflammatory serum markers to oral ERB-041 in subjects with inflammation associated with active Crohn's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ERB-041
Primary Outcome Measure Information:
Title
Inflammatory serum markers
Title
Pharmacogenomics
Title
Safety
Secondary Outcome Measure Information:
Title
Crohn's Disease Activity Index (CDAI) scores.
Title
Cell surface markers
Title
Fecal markers
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating ERB-041 in Active Crohn's Disease
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