Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2006 by NPS Pharmaceuticals.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

NPS Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00072839

First received: November 11, 2003

Last updated: January 20, 2009

Last verified: March 2006

Purpose

The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.

Condition	Intervention	Phase
Crohn's Disease	Drug: ALX-0600	Phase 2

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 Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects With Moderately Active Crohn's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Teduglutide

U.S. FDA Resources

Further study details as provided by NPS Pharmaceuticals:

Estimated Enrollment:	100
Study Start Date:	October 2003
Estimated Study Completion Date:	August 2005

Detailed Description:

The study is twelve weeks in duration and there are eight weeks of once-daily injections into your abdomen or thigh. There are a total of six visits.

Eligibility

Criteria

Inclusion Criteria

Signed and dated consent before any other study-related procedures are done.
A minimum of a 6-month diagnosis of Crohn's Disease.
Subject must be willing to adhere to the study visit schedule and other procedures.

Exclusion Criteria

Cardiovascular or other significant disease.
Nursing or pregnant mothers or women who are unwilling to use birth control.
Participation in a clinical study of an experimental drug or device within 30 days before signing consent.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072839

Sponsors and Collaborators

NPS Pharmaceuticals

Investigators

Study Director:

David Jacobs, MD

NPS Pharmaceuticals

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00072839 History of Changes
Other Study ID Numbers:	CL0600-008-01
Study First Received:	November 11, 2003
Last Updated:	January 20, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis

Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 22, 2013