Acromegaly Combination Treatment Study

What Was Tested

In this not phased trial, researchers set out to test Octreotide and Lanreotide.

It had three arms (groups): one (active comparator), one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Subjects will be stratified based on prior response to SRL therapy and then randomized to one of three treatment arms.

The study will begin when the combination of octreotide long-acting release (LAR) or lanreotide and pegvisomant is first administered.

Study visits will occur every 4 weeks from the start of the study.

However, for subjects who cannot make every study visit due to distance, the study team will facilitate monthly blood draws at their local Quest laboratory facility.

Who Took Part

Enrollment: 76 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Acromegaly patients on SRL monotherapy with normal or elevated IGF-1 levels. Acromegaly patients on Pegvisomant monotherapy with normal or elevated IGF-1 levels. Acromegaly patients who have received SRL and dopamine agonist therapy, after a 6 week washout period of the dopamine agonist. Normal liver function tests before randomization to treatment. The patient has had appropriate dynamic testing of the pituitary axis and, if applicable, is receiving appropriate hormone replacement therapy.

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: the patient harbors a macroadenoma with visual field defects due to chiasmatic compression; the patient had pituitary surgery within 3 months prior to study entry; the patient had radiotherapy within 12 months prior to study entry.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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

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

Being open-label, the Octreotide study did not mask who received what.

It started in 2012-03-29 with completion listed for 2022-05-20.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Octreotide and Lanreotide in 76 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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