Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure

What Was Tested

The trial (phase 2) is built around Pasireotide.

The angiodysplasias may be responsible for recurrent gastrointestinal bleeding and in some cases bleeding remaining inaccessible to endoscopic treatment.

No randomized studies are available.

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

1 injection per month during 6 months of the placebo product.

The registry classes the interventions as drug.

More on the Plan

The angiodysplasias are abnormal communications between dilated capillaries and veins.

The responsibility of aortic stenosis is debated and could be a chance association.

On the other hand, are more symptomatic bleeding in case of bleeding disorders, in particular von Willebrand disease.

The first line treatment is based on the destruction of endoscopic lesions by laser, or argon plasma coagulation electrocoagulation.

Who Took Part

24 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: Angiodysplasia of the stomach, small intestine or colon confirmed by endoscopy. 6 or more of packed red cells unit transfusion during the 6 months prior inclusion. Failed endoscopic therapy or cons-indication for endoscopic treatment. Patient affiliated to a social security insurance. Age \> 18 years.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: treatment with somatostatin analogue in the 6 months prior to inclusion; symptomatic cholelithiasis; rendu-osler disease.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Pasireotide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2012-03 with completion listed for 2012-03.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): number of red blood cells transfused (time frame: at 6 months).

What This Means in Plain Language

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