Lanreotide in the Treatment of Small Bowel Motility Disorders

What Was Tested

This registered phase 2 trial tested Lanreotide.

It is similar to a natural hormone somatostatin that is produced in the body in the stomach, duodenum, pancreas and brain.

Somatostatin is a growth hormone-inhibiting hormone.

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

Open label.

The registry classes the interventions as drug.

More on the Plan

The investigators hypothesize that in patients with small bowel motility disorders, Lanreotide helps in alleviating the symptoms.

Lanreotide is an FDA approved medication for management of acromegaly and neuroendocrine tumors, but has never been used for treating small bowel motility disorders.

However, Octreotide which is similar to Lanreotide but is a short acting synthetic somatostatin has been used in few research studies.

If a patient is interested and qualifies for the study then he/she will be explained about the study and signature will be collected on the consent form.

Who Took Part

The registry lists 12 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Aged between 18 and 70 years. Subjects should be capable of understanding the study and be able to give informed consent. Patient having small bowel motility disorder as evidenced by delayed small bowel transit by wireless motility capsule (WMC) testing to \> 6 hours.

The full record lists 5 inclusion and 30 exclusion criteria; among the exclusions: age \<18 or age \>70; pregnancy as assessed by urine pregnancy test; history of gastric bezoar.

How the Study Was Run

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

Being open-label, the Lanreotide 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 2017-05-11 with completion listed for 2018-10-21.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Effect of Lanreotide on Gastrointestinal Motility as Measured by Smart Pill (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Lanreotide in 12 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 Lanreotide compound page, all human trials.