Conditions: Short Bowel Syndrome
Keywords: SBS short bowel syndrome TPN parenteral nutrition PN
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 86
Healthy volunteers: no

Brief summary:
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with parenteral nutrition (PN) dependent Short Bowel Syndrome (SBS). Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. This study was designed to provide evidence of efficacy, safety, and tolerability of teduglutide 0.05 mg/kg daily in SBS subjects.

Detailed description:

Arms:
arm 1: 0.05 mg/kg/day sc dose of teduglutide arm 2: Matching subcutaneous dose of placebo to teduglutide

Interventions: intervention 1: teduglutide intervention 2: placebo
Intervention descriptions: intervention 1: 0.05 mg/kg/day sc injection for 24 weeks intervention 2: Matching daily subcutaneous dose of placebo to teduglutide for 24 weeks

Protocol document: