Long-term Safety and Efficacy Study of Octreotide Implant in Patients With Acromegaly

What Was Tested

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

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

The registry classes the interventions as drug.

More on the Plan

Evaluation on the long-term safety and tolerability, including local tolerability of the implant site, of the 84-mg octreotide hydrogel implant in subjects with acromegaly who had been successfully treated with the 84-mg octreotide hydrogel implant in the Phase III study IP107-001.

Who Took Part

The registry lists 12 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: Subjects who have been successfully treated with the 84-mg octreotide hydrogel implant in Study IP107 001. Subjects must be able to communicate, provide and sign written informed consent, and be willing to participate and comply with study requirements.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: pituitary surgery less than 3 months prior to enrollment into this study; liver disease (eg, cirrhosis, chronic active or persistent hepatitis or persistent abnormalities of alt, ast \[level \>2× normal\] or direct bilirubin \[level \>1.5× normal\]); unstable angina, sustained ventricular arrhythmias or heart failure (nyha iii and iv).

How the Study Was Run

Design: non-randomized, single-group and open-label.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2011-02 with completion listed for 2012-04.

It ran at 6 sites in United States (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Long term safety and tolerability of the Octreotide Implant (time frame: every 3 months for up to 2 years).

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Octreotide in 12 people.

Its size is small, so on its own it can only give an early look.

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.