Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome

PHASE3CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

May 25, 2004

Primary Completion Date

July 6, 2007

Study Completion Date

July 6, 2007

Conditions
Short Bowel Syndrome
Interventions
DRUG

Placebo

placebo injectable subcutaneously daily into thigh or abdomen

DRUG

Teduglutide 0.05 mg/kg/d

Teduglutide 0.05 mg/kg/d daily injectable subcutaneously into the thigh or abdomen

DRUG

Teduglutide 0.1 mg/kg/d

Teduglutide 0.1 /g/kg/d daily injection subcutaneously into thigh or abdomen

Trial Locations (32)

1070

l'Hôpital Erasme, Brussels

2100

Rigshospitalet, University of Copenhagen, Copenhagen

10029

Mount Sinai School of Medicine, New York

10117

Charité University Hospital, Berlin

12208

Albany Medical Center, Albany

13353

Charité-Universitätsmedizin Berlin, Berlin

14642

University of Rochester Medical Center, Rochester

15213

University of Pittsburgh Medical Center, Pittsburgh

19104

University of Pennsylvania - Penn Nursing, Philadelphia

20007

Georgetown University, Washington D.C.

29425

Medical University of South Carolina, Charleston

30322

Emory University Hospital, Atlanta

44195

The Cleveland Clinic Foundation, Cleveland

59037

Hôpital Claude-Huriez, Lille

60590

Universitätsklinikum Frankfurt, Frankfurt

60611

Northwestern Center for Clinical Research, Chicago

66160

University of Kansas Medical Center, Kansas City

68198

University of Nebraska Medical Center, Omaha

69317

Hôpital de la Croix-Rousse, Lyon

69437

Hôpital Edouard Herriot, Lyon

85259

Mayo Clinic Scottsdale, Scottsdale

92110

Hôpital Beaujon, Paris

02903

Rhode Island Hospital, Providence

T5H4B9

Royal Alexandra Hospital, Edmonton

V6Z1Y6

St. Paul's Hospital, Vancouver

M5B1W8

St. Michael's Hospital, Toronto

M5G2N2

Toronto General Hospital, Toronto

1100 DD

Academic Medical Center, Amsterdam

10-651

Pracownia Żywienia Klinicznego, Olsztyn

00-416

Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP, Warsaw

M68HD

Hope Hospital, Salford

HA13UJ

St. Mark's Hospital, Harrow

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY