Study to Assess Efficacy and Safety of Lanreotide Autogel [amount hidden] in Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction

What Was Tested

This registered phase 2 trial tested Lanreotide.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 52 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: Written informed consent before any study related procedure. Male and female patients age 18 years or older at time of enrollment. Diagnosis of intestinal obstruction of malignant origin. In case of peritoneal carcinomatosis, confirmation by CT or MRI scan within the 3 months preceding the inclusion in the study. Confirmed as inoperable after surgical advice.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: operable obstruction or subobstruction; bowel obstruction due to a non-malignant cause; signs of bowel perforation.

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 2014-11-19 with completion listed for 2017-11-09.

It ran at 17 sites in Belgium (17).

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Percentage of Responders Before or at Day 7 (time frame: From Day 0 to Day 7).

It also tracked 8 secondary outcomes, for example Percentage of Responders in Phase 1, Median Time Between First Lanreotide Autogel® Injection and Clinical Response in Phase 1, Median Change From Baseline in Quality of Life as Assessed by Edmonton Symptom Assessment System (ESAS) in Phase 1, Median Change From Baseline in General Activity as Assessed by the Karnofsky Performance Status (KPS) Scale in Phase 1, Median Change From Baseline in Number of Daily Episodes of Nausea in Phase 1 and Median Change From Baseline in Abdominal Pain Scores Assessed Using Visual Analogue Scale (VAS) in Phase 1.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Lanreotide in 52 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.