Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

Study Overview
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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.

Official Title
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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

Conditions
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Diarrhea

Intervention / Treatment
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* Drug: lanreotide (Autogel formulation)


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lanreotide (Autogel formulation) Autogel 120mg<br>lanreotide (Autogel formulation) Autogel 120mg | Drug: lanreotide (Autogel formulation)<br>* Autogel 120mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days) |  | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline | SF36 QOL includes 1 multi-item scale measuring each of 8 health concepts. These scores are summed to produce raw scale scores for each health concept which are transformed to a 0-100 scale. The lower the score the more disability. The higher the score the less disability. There is in addition a single-item measure of Health Transition IBS-QOL is a self-report QOL measure specific to IBS that can be used to assess impact of IBS and its treatment. This consists of 34 items,each with a 5 point response scale.Individual responses to 34 items are summed and averaged for a total score and transformed to a 0-100 scale with higher scores indicating better IBS specific QOL | Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56 | 
| Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline | Each patient scored his/her stool on the Bristol Stool Form Scale: Type 1 - Separate hard lumps, like nuts (hard to pass); Type 2 - Sausage-shaped but lumpy; Type 3 - Like a sausage but with cracks on its surface; Type 4 - Like a sausage or snake, smooth and soft; Type 5 - Soft blobs with clear-cut edges (passed easily); Type 6 - Fluffy pieces with ragged edges, a mushy stool; Type 7 - Water no solid pieces, Entirely liquid | Baseline (day 1), day 28 and day 56 | 
| Percent Change in Mean Number of Stools Compared to Baseline |  | Baseline (Day 1), Day 28 and Day 56 | 
| Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects | Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline. | Baseline (Day 1), Day 28 and Day 56 | 
| Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools |  | Day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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symptomatic treatment of patients with refractory diarrhea