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Study Evaluating ERB-041 in Active Crohn's Disease

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ClinicalTrials.gov Identifier: NCT00245947
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : September 10, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: ERB-041 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : April 2004
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Inflammatory serum markers
  2. Pharmacogenomics
  3. Safety

Secondary Outcome Measures :
  1. Crohn's Disease Activity Index (CDAI) scores.
  2. Cell surface markers
  3. Fecal markers

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245947


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00245947     History of Changes
Other Study ID Numbers: 3142A3-102
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: September 10, 2009
Last Verified: September 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Crohn's Disease
Inflammation

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases