Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly

What Was Tested

In this phase 3 trial, researchers set out to test Octreotide.

Octreotide capsule is a novel, orally-administered formulation of the commercially-available injectable drug octreotide.

It had two arms (groups): Octreotide capsules (active comparator) and Matching Placebo (placebo comparator).

Octreotide capsules.

Matching placebo capsules.

The registry classes the interventions as drug.

More on the Plan

Eligible acromegaly patients, treated with injectable somatostatin analogs, who are biochemically controlled and have prior evidence of active disease, will be randomized to receive either octreotide capsules or placebo for up to 36 weeks.

At the end of this double blind, placebo controlled period, eligible patients will receive octreotide capsules in an open-labeled extension for at least one year.

Patients failing to respond (per protocol), to oral treatment, (either placebo or octreotide capsules), will be rescued with the standard of care and upon meeting the eligibility criteria could also enroll into the long term extension with octreotide capsules.

This study received agreement from the FDA, under a special protocol assessment.

Who Took Part

The registry lists 56 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: Documented evidence of active acromegaly.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: patients taking injections of long-acting somatostatin receptor ligands (srls) not as indicated in the label; pituitary surgery within six months; conventional or stereotactic pituitary radiotherapy any time in the past.

How the Study Was Run

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

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

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

Blinding on both sides kept the participants and researchers unaware of who received Octreotide.

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

It started in 2017-09-01 with completion listed for 2019-06-13.

It ran at 60 sites in United States (19), Australia (6), Poland (5), Turkey (Türkiye) (4), Canada (3) and Hungary (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Patients Who Maintain Their Biochemical Response at the End of the Double Blind Placebo Controlled (DPC) Period (time frame: Week 36).

It also tracked 2 secondary outcomes, for example Number of Patients Who Maintain Growth Hormone (GH) Response at the End of the Double Blind Placebo Controlled Period and Number of Patients Who Begin Rescue Treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 56 people.

Its status is unknown; results are posted on the registry, and this page does not restate them.

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