Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diarrhea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lanreotide (Autogel formulation) Autogel 120mg

Group Type EXPERIMENTAL

lanreotide (Autogel formulation)

Intervention Type DRUG

Autogel 120mg

Interventions

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lanreotide (Autogel formulation)

Autogel 120mg

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No