NCT00798967

Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects

A 24-Week Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	teduglutide	0.05 mg/kg/day sc injection for 24 weeks
DRUG	placebo	Matching daily subcutaneous dose of placebo to teduglutide for 24 weeks

Timeline

• Start date: 2008-11-25
• Primary completion: 2011-01-25
• Completion: 2011-01-25
• First posted: 2008-11-27
• Last updated: 2021-06-03
• Results posted: 2012-02-01

Locations

35 sites across 10 countries: United States, Canada, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom