An Efficacy and Safety Study of Somatuline Depot (Lanreotide) Injection to Treat Carcinoid Syndrome

What Was Tested

This registered phase 3 trial tested Lanreotide.

It had two arms (groups): one (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

This study consisted of a Screening period, conducted up to 4 months before randomisation, followed by three phases: a 16-week, double blind (DB), randomised, placebo-controlled phase; a 32-week initial open label (IOL) phase; and a long term open label extension (LTOLE) phase.

The DB phase evaluated lanreotide Autogel versus placebo in subjects with a history of carcinoid syndrome (flushing and/or diarrhoea).

Subjects in countries where lanreotide Autogel had not been approved for the treatment of carcinoid syndrome, who were well-controlled at the end of the 32-week IOL phase and chose to continue to receive lanreotide Autogel, were given the option of participating in a LTOLE phase.

The actual overall duration of the study was 6.5 years.

Who Took Part

Enrollment: 115 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: Subjects must have given signed informed consent before any study related activities were conducted. Subjects must have been willing to receive s.c. octreotide injections as rescue medication, as needed to control their symptoms, if any. If female, the subject must not have been pregnant (confirmed by negative pregnancy test) and must have had the following documented via verbally given history:. At least 1 year postmenopausal (natural cessation of menses), or. Surgically sterile (if by tubal ligation, surgery must have been performed more than 3 months prior to entry into the study), or.

The full record lists 26 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Lanreotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2009-05 with completion listed for 2013-05.

It ran at 54 sites in United States (16), Ukraine (11), Brazil (7), India (7), South Africa (4) and Russia (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Days With Subcutaneous Octreotide as Rescue Medication (time frame: 16-week DB phase).

It also tracked 9 secondary outcomes, for example Average Frequency of Diarrhoea Events (Per Day) Based on Subject Diary Records, Average Frequency of Flushing Events (Per Day) Based on Subject Diary Records, Percentage of Days of Use of Other Rescue Medication, Proportion of Subjects Who Rolled Over Into the IOL Phase Before Completing the DB Phase of the Study, Absolute Changes From Baseline in Biochemical Markers (Plasma Chromogranin A [CgA]) and Absolute Changes From Baseline in Biochemical Markers (Urinary 5-hydroxyindoleacetic Acid [5-HIAA]).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Lanreotide in 115 people.

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.