An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004

Plain-language guide to NCT03596164: phase 3 interventional trial of Teduglutide (GLP-2 analog), 11 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT03596164
Phase: phase 3
Status: completed
Start: 2018-07-09
Completion (planned or actual): 2022-01-13
Participants: 11 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Short Bowel Syndrome
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Teduglutide (GLP-2 analog).

It had 1 arm (groups): one (experimental).

The registry classes the interventions as device and drug.

Who Took Part

Enrollment: 11 actual participants took part.

It was open to people of any sex aged from 16 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ability to voluntarily provide written, signed, and informed consent to participate in the study. Completion of the SHP633-306 study or participation in TED-C14-004 (NCT02340819) Stage 3 or Stage 4. Females of childbearing potential must agree to comply with the contraceptive requirements of the protocol. An understanding, ability, and willingness to fully comply with study procedures and restrictions.

The full record lists 4 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Teduglutide (GLP-2 analog) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2018-07-09 with completion listed for 2022-01-13.

It ran at 5 sites in Japan (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Weekly PS Volume (time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)). Percent Change From Baseline in Weekly PS Volume (time frame: Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)). Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Teduglutide (GLP-2 analog) in 11 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Teduglutide (GLP-2 analog) compound page, all human trials.

Our Notes on the Compound

Teduglutide (GLP-2 analog): A GLP-2 analog approved for short bowel syndrome (Gattex/Revestive); it helps the remaining gut absorb more and lowers IV nutrition needs.

Teduglutide (GLP-2 analog) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.