Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome
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|ClinicalTrials.gov Identifier: NCT00081458|
Recruitment Status : Completed
First Posted : April 14, 2004
Results First Posted : July 15, 2013
Last Update Posted : June 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Short Bowel Syndrome||Drug: Placebo Drug: Teduglutide 0.05 mg/kg/d Drug: Teduglutide 0.1 mg/kg/d||Phase 3|
Teduglutide is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the growth, proliferation, and maintenance of cells lining the gastrointestinal tract. Teduglutide has been shown in animal studies and previous human clinical trials to increase the size and number of these cells, thereby increasing the absorptive surface area of the intestines.
The multicenter, double-blind, international Phase III trial will randomly assign approximately 80 patients to receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight, or a placebo. Dosing will continue for a period of six months. The primary endpoint in the study is a reduction in the use of intravenous feeding, which is often required to sustain life in patients with SBS.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome|
|Actual Study Start Date :||May 25, 2004|
|Actual Primary Completion Date :||July 6, 2007|
|Actual Study Completion Date :||July 6, 2007|
Placebo Comparator: placebo
Placebo injectable subcutaneously daily into the thigh or abdomen
placebo injectable subcutaneously daily into thigh or abdomen
teduglutide 0.05 mg/kg/d
Drug: Teduglutide 0.05 mg/kg/d
Teduglutide 0.05 mg/kg/d daily injectable subcutaneously into the thigh or abdomen
Other Name: GATTEX
teduglutide 0.1 mg/kg/d
Drug: Teduglutide 0.1 mg/kg/d
Teduglutide 0.1 /g/kg/d daily injection subcutaneously into thigh or abdomen
Other Name: GATTEX
- A Graded Response Score in Parenteral Nutrition (PN) Reduction [ Time Frame: 6 months ]The intensity of the response relied on a reduction from Baseline in weekly parenteral nutrition (PN) volume (minimum reduction of 20% and a maximum of 100%). Duration of the response incorporated responses at Weeks(Wk) 16-20 and at Wk20-24. Zero (0 - lowest) assigned if <20% reduction at Wk20-24 and reduction at Wk16-20 of < 20%, 20-39%, or >=40%. One (1) assigned if reduction of 20-39% at Wk20-24 but < 20% at Wk16-20. Two(2) assigned if reductions of 40-99% at Wk20-24 AND <20% at Wk16-20 OR 20-39% at Wk20-24 AND 20-39% at Wk16-20. Three (3) assigned if reductions of 100% at Wk20-24 AND <20% at Wk16-20 OR 40-99% at Wk20-24 AND 20-39% at Wk16-20 OR 20-39% at Wk20-24 AND >=40% at Wk16-20. Four (4) assigned if reductions of 100% at Wk20-24 AND 20-39% at Wk16-20 OR 40-99% at Wk20-24 AND >=40% at Wk16-20.
- Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24 [ Time Frame: 6 months of treatment ]An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00081458
|Study Director:||Study Director||Takeda|