A PHASE II/III, MULTI-CENTRE, PROSPECTIVE, EXPLORATORY, OPEN LABEL STUDY TO ASSESS THE EFFICACY AND SAFETY OF LANREOTIDE AUTOGEL 120 MG IN THE SYMPTOMATIC TREATMENT OF PATIENTS WITH REFRACTORY DIARRHEA(MEDICAL APPROACH OF REFRACTORY DIARRHEA) - MEDARD

Phase 1

• Conditions: Refractory diarrhea; MedDRA version: 14.0Level: LLTClassification code 10012727Term: DiarrheaSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2009-009356-20-BE
• Lead Sponsor: IPSEN NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-15
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All subjects must fulfill the following:

•Male or female subject with a refractory diarrhea (> 3 stools / 24 hours) for at least 1 month, after normal extended work-up to exclude causes of diarrhea (such as duodenum scopy with biopsies, ileocolonscopy with biopsies, 72 hours stool collection, bile acid breath test and normal thyroid function), not or not enough responding to standard anti-diarrhetics (probiotics, astringents, absorbents and transit inhibitors or any combination) as evaluated by the investigator

•Subject having discontinued anti-diarrheic treatment (these are, but are not limited to, probiotics, astringents, absorbents and transit inhibitors or any combination) at screening

•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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects will not be included in the study if the subject:

•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,

•Had a weight of stool < 600 g in the last 72 hrs 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),

•Has a known intolerance to lanreotide or other somatostatin analogues,

•Is at risk of pregnancy or lactation, or is likely to father a child during the
study. Females of childbearing potential must provide a negative pregnancy
test at start of study and must be using double barrier or injectable
contraception. Non childbearing potential is defined as post-menopause for at
least 1 year, surgical sterilisation or hysterectomy at least three months before
the start of the study,

•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,

•Was treated with any other investigational drug within the last 3 months before study entry.

Study & Design

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