Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome

What Was Tested

This registered phase 2 trial tested Pasireotide.

It had 1 arm (groups): SOM230 (experimental).

Subjects with dumping syndrome treated with pasireotide.

The registry classes the interventions as drug.

More on the Plan

After completing Month 3, patients were switched to pasireotide LAR for 3 months (up to Month 6).

The core phase of the study was completed at the end of Month 6.

Who Took Part

43 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Male or female patients ≥ 18 years of age. Post-gastric or esophageal bypass surgery, matching one of the criteria below:. Bariatric surgery: more than 6 months before signing the informed consent. Esophageal cancer surgery: were disease free at study entry. Gastric cancer surgery: were at stage 0 or I and were disease free at study entry.

The full record lists 16 inclusion and 28 exclusion criteria; among the exclusions: bariatric patients who had lap band; patients with a current diagnosis of diabetes mellitus; patients who had failed treatment with somatostatin analogues for dumping syndrome in the past.

How the Study Was Run

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

Nothing was hidden in this open-label Pasireotide study: the participants and staff both knew the treatment.

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

It started in 2013-01-08 with completion listed for 2015-08-07.

It ran at 17 sites in United States (6), Belgium (4), France (3), Germany (2) and Netherlands (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Response Rate in Plasma Glucose Level (time frame: at Month 3 (M3)).

It also tracked 18 secondary outcomes, for example Response Rate in Plasma Glucose Level, Response Rate in Pulse Rate, Response Rate in Hematocrit Levels, Insulin Levels During OGTT, Glucagon Levels During OGTT and Glucagon-like Peptide 1 (GLP-1) Levels During OGTT.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Pasireotide in 43 people.

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

More context: the Pasireotide compound page, all human trials.