Somatuline Autogel Preference and Health Economy Study

What Was Tested

The trial (phase 4) is built around Lanreotide.

The primary aim of this study is to assess which method of lanreotide Autogel administration patients with neuroendocrine tumours prefer - self/partner administrations or healthcare provided administrations.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 26 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: Provision of written informed consent from the patient and their partner (if the partner will be administering the lanreotide Autogel injections during the self administration period). Male or female aged 18 years of age or older. Neuroendocrine tumour confirmed by biopsy and visible on radiology.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: has a history of hypersensitivity to the investigational medicinal product or drugs with a similar chemical structure; has a life expectancy less than a year, as judged by the investigator; the patient or their partner is not considered competent in injection technique, as judged by the investigator.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Lanreotide and who got the comparison, which limits bias.

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

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

It started in 2008-06 with completion listed for 2010-08.

It ran at 10 sites in Sweden (5), Norway (3) and Denmark (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Subject Preference for Self or Partner Administration (time frame: Between week 30 to 34).

It also tracked 9 secondary outcomes, for example Number of Patients Stating at Least One Injection Interfered With Daily Activities, Number of Patients Stating at Least One Injection Negatively Interfered With Psychological Wellbeing, Days Sick Leave, Total Number of Visits to HCP Due to Carcinoid Symptoms, Perceived Symptom Control Evaluation in Respect to Episodes of Flushing and Perceived Symptom Control Evaluation in Respect to Episodes of Diarrhoea.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Lanreotide in 26 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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