ABOUT THIS STUDY
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- 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
- 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
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating ERB-041 in Active Crohn's Disease | |||
Official Title ICMJE | 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 | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Crohn's Disease | |||
Intervention ICMJE | Drug: ERB-041 | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 22 | |||
Original Enrollment ICMJE | 48 | |||
Actual Study Completion Date ICMJE | April 2005 | |||
Actual Primary Completion Date | April 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Other inclusions apply Exclusion Criteria:
Within 48 hours before randomization
Other exclusions applies | |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00245947 | |||
Other Study ID Numbers ICMJE | 3142A3-102 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | September 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |