Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
|Short Bowel Syndrome||Drug: teduglutide 0.05 mg/kg/d Drug: teduglutide 0.10 mg/kg/d||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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)|
- Number of Subjects Achieving a 20% Reduction at Week 28 [ Time Frame: 28 weeks ]
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.
- Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use [ Time Frame: 6 months ]Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No)
|Study Start Date:||January 2005|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00172185
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|Study Director:||Clinical Development||NPS Pharma|