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

January 11, 2019 updated by: Ipsen

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aalst, Belgium, 9300
        • OLVZ Aalst
      • Antwerpen, Belgium, 2060
        • ZNA Antwerpen
      • Brugge, Belgium, 8310
        • AZ Sint Lucas Brugge
      • Edegem, Belgium, 2650
        • UZ Antwerpen #2
      • Genk, Belgium, 3600
        • ZOL
      • Gent, Belgium, 9000
        • UZ Gent
      • Gent, Belgium, 9000
        • AZ Maria Middelares
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • CHC Cliniques Saint Joseph
      • Montigny-le-Tilleul, Belgium, 6110
        • CHU A. Vesale
      • Wilrijk, Belgium, 2610
        • AZ Sint-Augustinus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lanreotide (Autogel formulation) Autogel 120mg
Autogel 120mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
Time Frame: Day 28
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
Time Frame: Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56

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
Time Frame: Baseline (day 1), day 28 and day 56
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
Time Frame: Baseline (Day 1), Day 28 and Day 56
Baseline (Day 1), Day 28 and Day 56
Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects
Time Frame: Baseline (Day 1), Day 28 and Day 56
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
Time Frame: Day 56
Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

April 30, 2009

First Submitted That Met QC Criteria

April 30, 2009

First Posted (Estimate)

May 1, 2009

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • I-48-52030-223
  • 2009-009356-20 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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