Octreotide Efficacy and Safety in First-line Acromegalic Patients

What Was Tested

The trial (phase 4) is built around Octreotide.

Goals of therapy are to eradicate the tumor, suppress GH secretion, normalize IGF-I levels, and preserve normal pituitary function.

It had 1 arm (groups): octrotide (experimental).

The registry classes the interventions as drug.

Who Took Part

20 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: Males and females 18 and \< 80 years old. Presence of a pituitary tumor (microadenoma or macroadenoma), documented by a MNR performed in the 12 weeks before enrolment. IGF-I levels over normal upper limits, e.g. 97 percentile (age- and sex-matched). Written Informed Consent before any procedure specific to the study. Inclus.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: compression of optic chiasm that produces any impairment of field of vision; intolerance to octreotide or to any component of sandostatin® lar® preparation; patients with an hepatic condition such as cirrhosis, active or persisting chronic hepatitis, or other hepatopathy of fast evolution.

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 2002-07 with completion listed for 2006-05.

It ran at 8 sites in Spain (8).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example To evaluate the effect of Sandostatin® LAR® on Health Related Quality of Life and To evaluate the ability of Sandostatin® LAR® to relieve acromegaly signs and symptoms.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Octreotide in 20 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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