Trial record 17 of 606 for:    "Crohn disease"

Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008

This study has been completed.
Sponsor:
Information provided by:
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00308438
First received: September 13, 2005
Last updated: August 11, 2008
Last verified: August 2008
  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 Disease
Drug: Teduglutide (ALX-0600)
Phase 2

NPS Pharmaceuticals has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Extension Study of the Safety and Efficacy of ALX-0600 in Subjects With Crohn's Disease Who Completed the Pilot Study Protocol CL0600-008

Resource links provided by NLM:


Further study details as provided by NPS Pharmaceuticals:

Primary Outcome Measures:
  • The percentage of subjects who are in remission (CDAI score less than 150) at week 12 of this study. [ Time Frame: 12 weeks after start of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary Outcomes:
  • The percentage of subjects (of those who achieved response in CL0600-008) who, at week 12 of this study, maintain the response they previously achieved. [ Time Frame: 12 weeks after study start ] [ Designated as safety issue: No ]
  • The percentage of subjects who did not respond in CL0600-008 who do respond at week 12 in this study

Enrollment: 67
Study Start Date: March 2004
Study Completion Date: June 2006
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
All subjects in the study dosed at 0.1 mg/kg teduglutide
Drug: Teduglutide (ALX-0600)
0.1 mg/kg injected subcutaneously daily
Other Name: teduglutide

Detailed Description:

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

  Eligibility

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

Inclusion Criteria:

  • Subjects must have completed participation in the Pilot Active Crohn's Disease Study.
  • Subjects must continue to meet all inclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:

    • CDAI score greater than 220
    • Stool samples not required
    • C-reactive protein levels are not an exclusion criterion

Exclusion Criteria:

  • Subject must continue to meet all exclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:

    • Participation in a clinical study of an experimental drug or device within 30 days before signing consent.
  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: NCT00308438

  Show 24 Study Locations
Sponsors and Collaborators
NPS Pharmaceuticals
Investigators
Study Director: David Jacobs, MD NPS Pharmaceuticals
  More Information

No publications provided

Responsible Party: Director of Clinical Operations, NPS Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00308438     History of Changes
Other Study ID Numbers: CL0600-009
Study First Received: September 13, 2005
Last Updated: August 11, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by NPS Pharmaceuticals:
Crohn Disease
Crohn's Disease

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

ClinicalTrials.gov processed this record on July 20, 2014