Acute Application of Pegvisomant and Octreotide in Acromegaly

What Was Tested

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

It had three arms (groups): 1 (no intervention), 2 (active comparator) and 3 (active comparator).

Patients with acromegaly on stable pegvisomant therapy.

The registry classes the interventions as drug.

Who Took Part

The registry lists 10 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: Patients with acromegaly currently on stable pegvisomant therapy. Patients with diabetes mellitus may be included. Glucose levels must be controlled regularly throughout the study. Patients must not be co-treated with any other medication for acromegaly.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: radiotherapy within the last 2 years; any relevant acute disease; history of hypersensitivity against any of the used drugs.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Octreotide and the comparison in turn, acting as their own control.

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

It started in 2008-01 with completion listed for 2008-03.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example The course of glucose, insulin and pegvisomant during the profiles.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide in 10 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.