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:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Show 26 Study Locations
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 April 16, 2014