Teduglutide in Short Bowel Syndrome Patients
April 22, 2021 updated by: Felix Harpain, Medical University of Vienna
Teduglutide in Short Bowel Syndrome Patients - A Way Back to Normal Life?
A retrospective analysis was performed using data of patients suffering from non-malignant SBS-IF.
They were treated with teduglutide in a multidisciplinary SBS-IF program at a single university medical center between June 2016 and June 2020.
Study Overview
Study Type
Observational
Enrollment (Actual)
17
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
SBS-IF patients receiving teduglutide for at least 6 months
Description
Inclusion Criteria:
- SBS-IF
Exclusion Criteria:
- < 18 years
- Incompliance
- < 6 months of treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
enteral autonomy
Time Frame: at least 6 months of teduglutide treatment
|
percentage of patients reaching complete discontinuation of parenteral support
|
at least 6 months of teduglutide treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2016
Primary Completion (ACTUAL)
June 1, 2020
Study Completion (ACTUAL)
June 1, 2020
Study Registration Dates
First Submitted
April 19, 2021
First Submitted That Met QC Criteria
April 22, 2021
First Posted (ACTUAL)
April 23, 2021
Study Record Updates
Last Update Posted (ACTUAL)
April 26, 2021
Last Update Submitted That Met QC Criteria
April 22, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 131290
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.