SOMATULINE Autogel [amount hidden] IN DUMPING SYNDROME

What Was Tested

In this phase 2 trial, researchers set out to test Lanreotide.

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

Patients receive a deep subcutanous injection of placebo every four weeks, three times. After a wash out of three weeks, they will receive somatuline 90 mh via a deep subcutanous injection every four weeks, three times.

The registry classes the interventions as drug.

More on the Plan

Dumping syndrome has characteristic alimentary and systemic manifestations.

It is one of the most common postprandial syndromes observed after extensive gastric surgery.

Dumping syndrome can be separated into an early and late phase depending on the occurrence of symptoms in relation to the time elapsed after a meal.

The early phase occurs because of rapid delivery of large amounts of osmotic active solids and liquids into the duodenum.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 18 years up to 100 years.

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

Examples of who could join: Patients with clinical suspect of a dumping syndrome with a total dumping score\* (early and late symptoms) ≥ 10, and. Documented spontaneous hypoglycemia (at least 1). Age \> 18 years.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: patients who have been treated with somatuline or sandostatine lar in the past; diabetes mellitus; coeliakie and giardia.

How the Study Was Run

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

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

Each person switched between Lanreotide and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Lanreotide, so expectations could not easily colour the readings.

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

It started in 2008-04 with completion listed for 2013-12-02.

It ran at 3 sites in Belgium (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from Baseline Total Dumping score after treatment with Somatuline [amount hidden] and after placebo.

It also tracked 2 secondary outcomes, for example Change in quality of life.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Lanreotide in 24 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 Lanreotide compound page, all human trials.