Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)

Plain-language guide to NCT02340819: phase 3 interventional trial of Teduglutide (GLP-2 analog), 11 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02340819
Phase: phase 3
Status: completed
Start: 2014-12-18
Completion (planned or actual): 2018-11-05
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

In this phase 3 trial, researchers set out to test Teduglutide (GLP-2 analog).

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

The registry classes the interventions as 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.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Teduglutide (GLP-2 analog) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2014-12-18 with completion listed for 2018-11-05.

It ran at 5 sites in Japan (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Stage 2: Absolute Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 (time frame: Baseline (stage 2), Week 24). Stage 2: Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 (time frame: Baseline (stage 2), Week 24). Stage 2: Absolute Change From Baseline in Number of Days Per Week of Parenteral Support (PS) Usage at Week 24 (time frame: Baseline (stage 2), Week 24).

It also tracked 7 secondary outcomes, for example Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-Inf) of Teduglutide in Plasma, Area Under the Concentration-Time Curve From Time Zero to the Last Time Point (AUC0-t) of Teduglutide in Plasma, Maximum Concentration (Cmax) of Teduglutide in Plasma, Time to Reach Maximum Observed Drug Concentration (Tmax) of Teduglutide in Plasma, Terminal Half-Life (t1/2) of Teduglutide in Plasma and Apparent Clearance (CL/F) of Teduglutide in Plasma.

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.