Dose Escalation of Octreotide-LAR as First-Line Therapy in Resistant Acromegaly

What Was Tested

This registered phase 4 trial tested Octreotide.

Since their introduction into clinical use approximately two decades ago, somatostatin analogs have been considered a cornerstone of medical therapy for acromegaly.

The registry classes the interventions as drug.

More on the Plan

Primary outcome measures were GH and IGF-I control and tumor shrinkage; secondary outcome measure was glucose tolerance.

Serum IGF-I levels twice in a single sample at the time 0 of the GH profile; GH levels calculated as the mean value of 3-6 samples drawn every 30 min; the average value was considered for the statistical analysis; 2.

Tumor volume on MRI studies performed on clinical 1T and 1.5T scanners, using T1 weighted gradient recalled-echo in the sagittal and coronal planes, as already reported (15,21,22).

Who Took Part

Enrollment: 50 planned participants were the target.

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: Patients with newly diagnosed acromegaly. Age above 18 years. No previous treatments for acromegaly.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: primary surgery; concomitant hyperprolactinemia if requiring combined treatment with dopamine-agonist; primary treatment with lanreotide.

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 1995-01 with completion listed for 2006-12.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: GH and IGF-I control. tumor shrinkage.

It also tracked 1 secondary outcome, for example Glucose tolerance.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Octreotide in 50 people.

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.