Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients

What Was Tested

The trial (phase 2) is built around Lanreotide.

(A responder patient will be defined either as a patient experiencing \< or= 1 vomiting episode per day during at least three consecutive days or as a patient in whom NGT has been removed without any vomiting recurrence during at least three consecutive days) The total number of visits will depend on the clinical situation, 5 visits are obligatory: Day(D)-3/-0,Day 1,Day 7,Day 14,Day 28 Inclusion visit (D-3/-0): eligibility, PIC, obstruction history, clinical exam, vital signs, diary cards, VAS scale, cc medication, blood sample Visit D1: injection Visit D7/D14/28: clinical exam, nutrition procedure, result of biochemical analyse, adverse events, cc medication In between the visits, the patient will keep and fill out his diary and VAS scale.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 40 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: \>= 18 years at time of enrolment. Diagnosis of a digestive obstruction of malignant origin. Diagnosis of peritoneal carcinomatosis confirmed by a ct scan within the previous 3 months. Inoperability as decided after surgical consultation.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: operable obstruction; bowel obstruction that can be explained by a non malignant cause; signs of bowel obstruction.

How the Study Was Run

It was run as a non-randomized, 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 2009-10 with completion listed for 2013-07.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of responder patients (time frame: At day 7 and day 14).

It also tracked 7 secondary outcomes, for example Number of daily vomiting episodes on diary cards or measurements of the daily drainage by naso gastric tube (NGT), Number of days without vomiting episodes, Number of daily nausea episodes recorded on diary cards, Intensity of abdominal pain assessed on a visual analogue scale, Well-being assessed on a visual analogue scale and Time between first injection and clinical response.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Lanreotide in 40 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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