Efficacy and Safety of Octreotide (MYCAPSSA™ [Formerly Octreolin™]) for Acromegaly

What Was Tested

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

MYCAPSSA™ (formerly Octreolin™) is a proprietary oral form of the approved injectable medical product octreotide used to treat acromegaly.

It had 1 arm (groups): Octreotide capsules (experimental).

The registry classes the interventions as drug.

More on the Plan

The study consisted of 2 periods, a Core Treatment Period of up to 7 months and an optional Extension Treatment Period of up to 6 months, for a total study duration of up to 13 months.

The same criteria were used to allow entry into the voluntary 6-month Extension Treatment Period.

Who Took Part

155 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Adult subjects, aged 18 to 75 years old, inclusive. A serum IGF-1 level \< 1.3 x the upper limit of normal (ULN) and a serum growth hormone (GH) level \< 2.5 ng/mL. Subjects able and willing to comply with the requirements of the protocol. Subjects able to swallow capsules. Subjects able to understand and sign written informed consent to participate in the study.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: receiving regular injections of a somatostatin analog less frequently than once a month, ie, longer than every 4 weeks; symptomatic cholelithiasis; received pituitary radiotherapy within ten years prior to screening.

How the Study Was Run

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

Nothing was hidden in this open-label Octreotide 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 2012-03 with completion listed for 2014-05.

It ran at 36 sites in Germany (5), Poland (5), Hungary (4), United Kingdom (4), Italy (3) and Mexico (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Responders at the End of the Core Treatment Period (time frame: End of the core treatment period (up to 7 months)). Percentage of Responders at the End of the Extension Treatment Period (time frame: End of the extension treatment period (up to 13 months)).

It also tracked 6 secondary outcomes, for example Percentage of Participants With Specified IGF-1 and GH Concentrations at Baseline and at the End of the Core Treatment Period, Percentage of Participants With Specified IGF-1 and GH Concentrations at the Beginning and at the End of the Extension Treatment Period, Maintenance of Response During the Extension Treatment Period and Percentage of Participants With ≥ 1, 2, or 3 Acromegaly Symptoms at Baseline and at the End of the Extension Treatment Period.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Octreotide in 155 people.

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

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