Study to Evaluate Patients With Acromegaly Treated With Lanreotide Autogel (Somatuline ATG)

What Was Tested

This registered phase 2 trial tested Lanreotide.

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

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: the patient has received pituitary radiation therapy of any kind at any time prior to visit 1; the patient has received pituitary surgery within 3 months prior to visit 1; the patient's serum creatinine is higher than 150 µmol/l.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Lanreotide 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 2008-05 with completion listed for 2008-12.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Acromegaly symptoms (time frame: Weeks 16, 18 & 20). Indices of insulin secretion & sensitivity (time frame: Weeks 16, 18 & 20). Adverse events (time frame: Throughout study).

It also tracked 3 secondary outcomes, for example Number of patients with GH levels ≤ 2.5 ng/mL and the number of patients with IGF-1 level < upper limit of normal (ULN) and ECG and gallbladder ultrasound.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Lanreotide in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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