Malignant Intestinal Obstruction Clinical Trial
Official title:
Prospective Study to Assess the Efficacy and Safety of Lanreotide 120 mg as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients
The primary objective of this study is to assess the efficacy of Lanreotide 120 mg for the
relief of clinical symptoms due to malignant bowel obstruction in inoperable patients. This
effect will be evaluated by the percentage of responder patients 7 and 14 days after one
administration of lanreotide 120 mg.
(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
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment