Efficacy and Safety Study of Octreotide Implant in Patients With Acromegaly

What Was Tested

The trial (phase 3) is built around Octreotide.

It had two arms (groups): 1 (active comparator) and 2 (active comparator).

The registry classes the interventions as drug.

More on the Plan

This study will be conducted in 3 phases: Screening, the Primary Treatment Phase (ie, Day 1 to Week 24), and the Extension Phase (Post Week 24 to Week 48).

Who Took Part

The registry lists 169 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Male and female patients with acromegaly. Confirmed diagnosis of a growth hormone-secreting tumor.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: patients with pituitary surgery less than 3 months prior to screening; symptomatic cholelithiasis; received pegvisomant, lanreotide, or a dopamine agonist within 3 months of screening, or at any time during the trial.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

The Octreotide group and the comparison group ran side by side rather than switching.

Everyone knew when Octreotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2008-09 with completion listed for 2011-02.

It ran at 47 sites in Russia (15), United States (8), Germany (8), Poland (5), Hungary (3) and Spain (3).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 169 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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