Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NPS Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00172185
First received: September 13, 2005
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.


Condition Intervention Phase
Short Bowel Syndrome
Drug: teduglutide 0.05 mg/kg/d
Drug: teduglutide 0.10 mg/kg/d
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Study of the Safety and Efficacy of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

Resource links provided by NLM:


Further study details as provided by NPS Pharmaceuticals:

Primary Outcome Measures:
  • Number of Subjects Achieving a 20% Reduction at Week 28 [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

    For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use.

    For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use.



Secondary Outcome Measures:
  • Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No)


Enrollment: 65
Study Start Date: January 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: teduglutide 0.05 mg/kg/d
0.05 mg/kg/d teduglutide subcutaneous injection
Drug: teduglutide 0.05 mg/kg/d
0.05 mg/kg/d subcutaneous injection
Other Name: GATTEX
Experimental: teduglutide 0.10 mg/kg/d
0.10 mg/kg/d teduglutide subcutaneous injection
Drug: teduglutide 0.10 mg/kg/d
0.10 mg/kg/d subcutaneous injection
Other Name: GATTEX

Detailed Description:

Teduglutide is an analog of naturally occurring human glucagon-like peptide-2 (GLP-2), a peptide secreted by L-cells of the distal intestine. GLP-2 is known to increase intestinal and portal blood flow, and inhibit gastric acid secretion. Teduglutide binds to the glucagon-like peptide-2 receptors located in intestinal subpopulations of enteroendocrine cells, subepithelial myofibroblasts and enteric neurons of the submucosal and myenteric plexus. Activation of these receptors results in the local release of multiple mediators including insulin-like growth factor (IGF)-1, nitric oxide and keratinocyte growth factor (KGF).

This multicenter, double-blind, international, Phase III trial will have a treatment period of 28 weeks. Subjects in this study are those who received teduglutide or placebo in protocol CL0600-004 (NCT00081458). These subjects will receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight. Subjects will have visits every 4 to 6 weeks and will be assessed for parenteral nutrition (PN) reduction with a follow-up period of 4 weeks duration for those subjects who do not complete this protocol, or do not enter into the long-term safety extension protocol CL0600-010.

  Eligibility

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

Inclusion Criteria:

At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study.

Subjects who meet all of the following criteria can be enrolled in this study:

  • Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed
  • Completion of protocol CL0600-004 (NCT00081458)

Exclusion Criteria:

  • History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state
  • History of alcohol or drug abuse (within previous year)
  • Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit
  • Pregnant or lactating women
  • Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results
  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: NCT00172185

  Show 21 Study Locations
Sponsors and Collaborators
NPS Pharmaceuticals
Investigators
Study Director: Clinical Development NPS Pharmaceuticals
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NPS Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00172185     History of Changes
Other Study ID Numbers: CL0600-005
Study First Received: September 13, 2005
Results First Received: March 12, 2013
Last Updated: June 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by NPS Pharmaceuticals:
Short Bowel Syndrome
Parenteral Nutrition
SBS
Teduglutide

Additional relevant MeSH terms:
Short Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014