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NCT00930644 · ClinicalTrials.gov registry record · Phase 3

Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

A Phase 3 study of Short Bowel Syndrome, sponsored by Shire.

Completed
Registry status
Phase 3
Development phase
88
Enrollment target
20
Study locations

NCT00930644 is a Phase 3 study of Short Bowel Syndrome that has completed, run by Shire. The registered enrollment target is 88 participants, below the 180-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT00930644, a Phase 3 study of Short Bowel Syndrome, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 3
Development phase
88 participants
Enrollment target
20
Study locations

Study Summary

This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.

Conditions Studied

Interventions

  • DRUG teduglutide

Study Locations (20)

Other

  • Rigshospitalet - Copenhagen
  • Hôpital Beaujon - Clichy
  • Hopital de l'Archet 2 - Nice
  • Azienda Universitaria Policlinico Federico II - Naples
  • Wojewodzki Szpital Specjalistyczny im. M. Pirogowa, Pracownia Leczenia Zywieniowego - Lodz
  • Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Chirurgii Ogolnej i Transplantacyjnej - Lublin
  • Pracownia Żywienia Klinicznego - Olsztyn
  • Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP - Warsaw
  • Hospital Universitario de Bellvitge - Barcelona

Pennsylvania

  • University of Pennslyvania - Philadelphia
  • University Of Pittsburgh Medical Center - Pittsburgh

Ontario

  • St. Michael's Hospital - Toronto
  • University Health Network - Toronto General Hospital - Toronto

California

  • Scripps Clinic & Research Foundation - La Jolla

New York

  • Mount Sinai Medical Center - New York

Ohio

  • Cleveland Clinic Foundation - Cleveland

Tennessee

  • Vanderbilt University Medical Center - Nashville

Alberta

  • Royal Alexandra Hospital - Edmonton

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2009-09-21
Est. Completion 2013-01-24
Phase Phase 3

Sponsor

Shire

245 total trials

What the Registry Record Tells You About NCT00930644

The ClinicalTrials.gov registry entry for NCT00930644 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 180-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (51% lower). The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Short Bowel Syndrome appearing as the primary indexed condition, and to 1 intervention - of which teduglutide is the first listed.

NCT00930644 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, Pennsylvania, Ontario.

Frequently Asked Questions

What is clinical trial NCT00930644 about?

NCT00930644 is a clinical study titled "Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)". This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.

What is the current status of trial NCT00930644?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 88 participants. The study started on 2009-09-21. Estimated completion is 2013-01-24.

What conditions does trial NCT00930644 study?

This clinical trial studies the following conditions: Short Bowel Syndrome.

What interventions are being tested in trial NCT00930644?

The interventions under investigation include: teduglutide (DRUG).

Who is sponsoring clinical trial NCT00930644?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00930644 being conducted?

This trial has 20 study locations across California, New York, Ohio, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.