Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients

What Was Tested

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

Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly.

Octreotide LAR is approved for treatment of acromegaly after surgery if the disease is not controlled.

The registry classes the interventions as drug.

Who Took Part

100 planned participants were the target.

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

Examples of who could join: Newly diagnosed or previously untreated acromegalic patients. Insulin-like growth factor-I (IGF-I) levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender).

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: no evidence of pituitary adenoma on magnetic resonance imaging (mri); symptomatic cholelithiasis.

How the Study Was Run

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

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

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

It started in 2002-12 with completion listed for 2004-08.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean GH and IGF-I at baseline, week 12, 24 and 48.

It also tracked 3 secondary outcomes, for example Tumor volume at baseline, week 24 and 48, Signs and symptoms of acromegaly at baseline, week 12, 24 and 48 and Safety and tolerability at any time on treatment.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Octreotide in 100 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.