Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome

What Was Tested

The trial (phase 2) is built around Pasireotide.

Dumping Syndrome consists of (1) a too rapid gastric emptying, (2) an inappropriate release of GI hormones (as a reaction to the hyperosmolar contents in the duodenum) and (3) an hyperinsulinemic response to a too rapid absorption of glucose.

It had two arms (groups): Pasireotide (experimental) and Placebo (placebo comparator).

Saline s.c. t.i.d.

The registry classes the interventions as drug.

More on the Plan

This will be a single centre, randomized, double-blind, controlled cross-over study during 35 days.

After a 4 weeks screening period, patients who fulfill the entrance criteria will be randomly assigned on a 1:1 basis to either the pasireotide treatment arm or to the placebo treatment arm.

They will be treated with pasireotide sc or placebo sc for 2 weeks.

After 2 weeks, patients will be switched to the other treatment arm after a 7 days wash out period.

Who Took Part

The registry lists 9 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Male or female patients aged between 18 and 80 years. Patients with diagnosis of Dumping Syndrome:. Having symptoms of Dumping Syndrome (sum of combined Dumping Syndrome score ≥10) AND. Either (a) having had a documented episode of postprandial hypoglycemia in the medical history. Patients for whom written informed consent to participate in the study has been obtained. Patients will need to provide their informed consent prior to starting any medication washout period.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: patients who have undergone major surgery/surgical therapy for any cause within 1 month; patients with symptomatic cholecystolithiasis in the medical history unless a cholecystectomy is performed (ultrasound abdomen maximum 6 months old); patients who have been treated with somatostatin analogues during the last 12 weeks before inclusion.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Pasireotide and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Pasireotide and the comparison in turn, acting as their own control.

As a double-blind Pasireotide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2008-09 with completion listed for 2010-01.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Effect on hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Pasireotide in 9 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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