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:

Genetics Home Reference related topics: Crohn disease

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 Inflammatory Bowel Diseases Gastroenteritis	Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases

ClinicalTrials.gov processed this record on September 26, 2016

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