Study Evaluating ERB-041 in Active Crohn's Disease

This study is ongoing, but not recruiting participants.

First Received: October 26, 2005 Last Updated: May 18, 2006 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00245947

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 I

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Wyeth:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	48
Study Start Date:	April 2004

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245947

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3142A3-102
Study First Received:	October 26, 2005
Last Updated:	May 18, 2006
ClinicalTrials.gov Identifier:	NCT00245947 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Crohn's Disease
Inflammation

Study placed in the following topic categories:

Crohn's Disease
Digestive System Diseases
Gastrointestinal Diseases
Ileitis
Enteritis
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases
Ileal Diseases
Inflammation

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases
Ileitis
Enteritis
Crohn Disease

Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Ileal Diseases

ClinicalTrials.gov processed this record on May 07, 2009