Conditions: Short Bowel Syndrome
Keywords: Short Bowel Syndrome Parenteral Nutrition SBS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 84
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).

Detailed description:
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.

Arms:
arm 1: Placebo injectable subcutaneously daily into the thigh or abdomen arm 2: teduglutide 0.05 mg/kg/d arm 3: teduglutide 0.1 mg/kg/d

Interventions: intervention 1: Placebo intervention 2: Teduglutide 0.05 mg/kg/d intervention 3: Teduglutide 0.1 mg/kg/d
Intervention descriptions: intervention 1: placebo injectable subcutaneously daily into thigh or abdomen intervention 2: Teduglutide 0.05 mg/kg/d daily injectable subcutaneously into the thigh or abdomen intervention 3: Teduglutide 0.1 /g/kg/d daily injection subcutaneously into thigh or abdomen

Protocol document: