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: September 26, 2014
Last verified: September 2014

September 13, 2005
September 26, 2014
January 2005
January 2008   (final data collection date for primary outcome measure)
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.

To evaluate the long-term safety and tolerability of daily teduglutide dosing for up to 12 months in adult subjects with SBS dependent on PN.
Complete list of historical versions of study NCT00172185 on ClinicalTrials.gov Archive Site
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)
The secondary objectives of this study are to evaluate the long-term effects of teduglutide dosing on reductions in PN for those subjects who received teduglutide or placebo in protocol CL0600 004.
Not Provided
Not Provided
 
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
A Study of the Safety and Efficacy of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Short Bowel Syndrome
  • Drug: teduglutide 0.05 mg/kg/d
    0.05 mg/kg/d subcutaneous injection
    Other Name: GATTEX
  • Drug: teduglutide 0.10 mg/kg/d
    0.10 mg/kg/d subcutaneous injection
    Other Name: GATTEX
  • Experimental: teduglutide 0.05 mg/kg/d
    0.05 mg/kg/d teduglutide subcutaneous injection
    Intervention: Drug: teduglutide 0.05 mg/kg/d
  • Experimental: teduglutide 0.10 mg/kg/d
    0.10 mg/kg/d teduglutide subcutaneous injection
    Intervention: Drug: teduglutide 0.10 mg/kg/d

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United States,   France,   Belgium,   Poland,   Denmark,   United Kingdom,   Canada
 
NCT00172185
CL0600-005
Yes
NPS Pharmaceuticals
NPS Pharmaceuticals
Not Provided
Study Director: Clinical Development NPS Pharmaceuticals
NPS Pharmaceuticals
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP