Study of Teduglutide in Japanese Participants With Short Bowel Syndrome

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

The registry lists 7 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. Male or female 16 years of age or older at the time of signing informed consent. Parenteral nutrition requirement of at least 3 times per week during the week before the screening visit and during the 2 weeks prior to the baseline visit. 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 8 inclusion and 18 exclusion criteria; among the exclusions: use of glucagon-like peptide (glp)-2 or human growth hormone or analogs of these hormones within the past 6 months; use of octreotide, glp-1 analogs, dipeptidyl peptidase-iv inhibitors, or enteral glutamine within 30 days; previous use of teduglutide.

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 2018-07-06 with completion listed for 2019-08-06.

It ran at 5 sites in Japan (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) (time frame: Baseline, EOT/ET (up to Week 28)). Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) (time frame: Baseline, EOT/ET (up to Week 28)). Change From Baseline in Days Per Week of Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET) (time frame: Baseline, EOT/ET (up to Week 28)).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Teduglutide (GLP-2 analog) in 7 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.