Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

June 2, 2022

Primary Completion Date

November 25, 2022

Study Completion Date

December 29, 2022

Conditions
Ileostomy - Stoma
Interventions
DRUG

Teduglutide

"Teduglutide (Gattex, Shire) was approved by the FDA in 2012 for use in adult patients with short bowel syndrome requiring parenteral support only.~The results of this study will not be used to justify a change of indication, or dose currently approved for Teduglutide, and will not be used to advertise the drug. This study meets all of the requirements for exemption from the IND regulations and an IND exemption has been confirmed by the FDA."

DRUG

Placebo

Placebo

Trial Locations (1)

15212

Allegheny General Hospital, Pittsburgh

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Shire

INDUSTRY

lead

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

OTHER