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Study Evaluating ERB-041 in Active Crohn's Disease

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00245947
First received: October 26, 2005
Last updated: September 9, 2009
Last verified: September 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Crohn's Disease
 Drug: ERB-041
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

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

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Inflammatory serum markers
  • Pharmacogenomics
  • Safety

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

Enrollment: 22
Study Start Date: April 2004
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00245947     History of Changes
Other Study ID Numbers: 3142A3-102
Study First Received: October 26, 2005
Last Updated: September 9, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 16, 2013