A PHASE II, SINGLE-CENTRE, PROSPECTIVE EXPLORATORY TRIAL TO ASSESS THE EFFICACY OF LANREOTIDE AUTOGEL 120 MG IN THE SYMPTOMATIC TREATMENT OF ACUTE RADIATION INDUCED DIARRHEA

Phase 1

• Conditions: radiation induced diarrhoea; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-001790-33-BE
• Lead Sponsor: niversity Hospital Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-12
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

•Male or female patient with radiation induced diarrhoea requiring daily loperamide intake (=16mg) for at least 3 consecutive days.
•Administration of lanreotide 120mg at least 7 days before ending radiotherapy.
•= 3 stools per 24 hours before radiotherapy
•> 3 stools per 24 hours in the screening period.
•Subject having provided written informed consent prior to any study related procedures
•Subject of 18 years and older
•Subject mentally fit for completing a diary
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•Has already received a treatment with somatostatin analogues for the treatment of refractory diarrhea,
•Has received a treatment with somatostatin analogues for any other indication within the last 6 months before study entry,
•Has received a treatment with laxatives within the last week before study entry,
•Suffers from IBS with alternating bowel habits and predominant constipation,
•Suffers from infectious and/or inflammatory gastro-enteritis (colitis ulcerosa, crohn´s disease and macroscopic colitis),
•Has a known intolerance to lanreotide or other somatostatin analogues,
•Has abnormal baseline findings or any other medical condition(s) that, in the opinion of the Investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified