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

PHASE3CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

November 25, 2008

Primary Completion Date

January 25, 2011

Study Completion Date

January 25, 2011

Conditions
Short Bowel Syndrome
Interventions
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

Trial Locations (35)

2100

Rigshospitalet - Abdominalcentret, Hepatologisk Kilinik A, Copenhagen

10029

Mount Sinai Medical Center, New York

10126

Azienda Ospedaliera Universitaria S. Giovanni Battista - Le Molinette, Torino

13353

Med. Klinik m.S. Hepatologie und Gastroenterologie, Berlin

15213

University Of Pittsburgh Medical Center, Pittsburgh

19104

University of Pennslyvania, Philadelphia

20010

Washington Hospital Center, Washington D.C.

22297

Israelitisches Krankenhaus, Hamburg

28041

Hospital Universitario 12 de Octubre, Madrid

30322

Emory University School of Medicine, Atlanta

32224

Mayo Clinic Jacksonville, Jacksonville

37232

Vanderbilt University Medical Center, Nashville

40138

Policlinico Sant'Orsola - Malpighi centro insufficienza intestinale, Bologna

44195

Cleveland Clinic Foundation, Cleveland

66160

Kansas University Medical Center, Kansas City

72076

Universitaetsklinikum Tuebingen, Tübingen

80131

Azienda Universitaria Policlinico Federico II, Napoli

92037

Scripps Clinic & Research Foundation, La Jolla

92110

Hôpital Beaujon, Clichy

02903

Rhode Island Hospital, Providence

T5H 3V9

Critical Care Research, Royal Alexandra Hospital, Edmonton

L8N 3Z5

Hamilton Health Sciences Centre, Hamilton

M3H 5S4

Polyclinic Family and Specialty Medicine Facility, North York

M5G 2N2

University Health Network - Toronto General Hospital, Toronto

Unknown

Hôpital Croix Rousse Unité de Nutrition Clinique Intensive, Lyon

06100

Hôpital de l'Archet Pôle Digestif, Nice

6525 GA

Universitair Medisch Centrum St. Radboud, Nijmegen

90-531

Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego, Lodz

20-954

Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej, Lublin

10-561

Wojewodzki Szpital Specjalistyczny,, Olsztyn

00-416

Samodzielny Publiczny Szpital Kliniczny im. prof W. Orlowskiego CMKP, Oddzial Kliniczny Zywienia i Chirurgii, Warsaw

08907

Hospital Universitario de Bellvitge, Barcelona

HA1 3UJ

St. Mark's Hospital Northwick Park, Harrow

NW1 2BU

University College Hospital, London

M6 8HD

Green Area, Main Hospital Salford Royal Hospitals NHS Foundation Trust, Manchester

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Nycomed

INDUSTRY

lead

Shire

INDUSTRY