Efficacy of Octreotide Acetate and Cabergoline in Patients With Acromegaly

What Was Tested

In this phase 4 trial, researchers set out to test Octreotide.

It had 1 arm (groups): SMS995 + Carbegolin, Somavert + SMS995 (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 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: Male and female patients (\> 18 years) with prior surgery of micro- or macroadenoma of the pituitary. Patient's written informed consent.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: radiotherapy planned or radiotherapy for acromegaly within the last 2 years; symptomatic cholelithiasis that is clinically relevant; receiving treatment with dopamine agonists within the last 6 months or prior treatment with gh-receptor-antagonists.

How the Study Was Run

The set-up was 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 2006-03 with completion listed for 2010-01.

It ran at 16 sites in Germany (16).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Biochemical control (% of patients) as measured by GH- and IGF-1-values (baseline, EOS) (time frame: 8 months).

It also tracked 5 secondary outcomes, for example Effect of tumor size, Biochemical control (mean, normalization) as measured by GH- and/or IGF-1-values, Control clinical of symptoms of acromegaly, Quality of Life assessment and Safety and tolerability as assessed by frequency of AEs.

What This Means in Plain Language

Put simply, this is a phase 4 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.