Comparable Effects of Lanreotide Autogel and Octreotide LAR on GH, IGF-I Levels and Patient Satisfaction

What Was Tested

The trial (phase 4) is built around Octreotide and Lanreotide.

The morbidity and the mortality in acromegalic patients closely correspond to growth hormone (GH) levels and therefore efficient long-term treatment is important.

Neurosurgery is the first choice of treatment in acromegalic patients.

The registry classes the interventions as drug.

More on the Plan

Introduction The morbidity and the mortality in acromegalic patients closely correspond to growth hormone (GH) levels and therefore efficient long-term treatment is important (1).

Somatostatin analogues have successfully been used in treatment of acromegaly if surgery or radiotherapy can not lead to normal GH and IGF-I levels (2, 3, 4, 5).

Inclusion criteria * all the patients which receive octreotide LAR can be included; * new diagnosed patients with clinical and biochemical acromegaly , if medicine therapy is indicated; * as long as they do not fit in the exclusion criteria.

Exclusion criteria * which had not given their consent after they received standard information about the study; * current malign disease; * somatostatin analogues intolerance; * elevation of lever enzymes; * pregnancy.

Who Took Part

Enrollment: 12 planned participants were the target.

It was open to people of any sex aged from 22 years up to 72 years.

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

Examples of who could join: All the patients which receive octreotide LAR can be included;. New diagnosed patients with clinical and biochemical acromegaly , if medicine therapy is indicated;. As long as they do not fit in the.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: which had not given their consent after they received standard information about the study;; current malign disease;; somatostatin analogues intolerance;.

How the Study Was Run

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

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

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

Being open-label, the Octreotide study did not mask who received what.

It started in 2002-09 with completion listed for 2004-12.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: GH and IGF-I levels after 4, 6, 10, 12 months therapy.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide and Lanreotide in 12 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 and the Lanreotide compound page, all human trials.