Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

A Phase II-III, Multicentre, Prospective, Exploratory, Open Label Study to Assess the Efficacy and Safety of Lanreotide Autogel 120mg in the Symptomatic Treatment of Patients With Refractory Diarrhea

The purpose of this study, is to assess the effect of lanreotide Autogel 120mg on stool frequency in subjects with refractory diarrhea at day 28 (mean of last 7 days) compared to baseline.

Inclusion Criteria:

• Male/female with refractory diarrhea for at least 1 month, after normal extended work-up to exclude causes of diarrhea, not or not enough responding to standard anti-diuretics as evaluated by the investigator
• Patient mentally fit for completing a diary

Exclusion Criteria:

• Has already received a treatment with somatostatin analogues for the treatment of refractory diarrhea
• Had a weight of stool < 600g in a 72hrs stool collection
• 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)