Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea (MEDARD)

Ipsen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diarrhea

Treatments: Drug: lanreotide (Autogel formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00891371

2009-009356-20 (EudraCT Number)

I-48-52030-223

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

lanreotide (Autogel formulation) Autogel 120mg

Experimental group

Description:

lanreotide (Autogel formulation) Autogel 120mg

Treatment:

Drug: lanreotide (Autogel formulation)