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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00891371
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : September 29, 2015
Last Update Posted : January 15, 2019
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diarrhea Drug: lanreotide (Autogel formulation) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: lanreotide (Autogel formulation) Autogel 120mg
lanreotide (Autogel formulation) Autogel 120mg
Drug: lanreotide (Autogel formulation)
Autogel 120mg

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Percent Change in Mean Number of Stools Compared to Baseline [ Time Frame: Baseline (Day 1), Day 28 and Day 56 ]
  4. 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.

  5. Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools [ Time Frame: Day 56 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00891371

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OLVZ Aalst
Aalst, Belgium, 9300
ZNA Antwerpen
Antwerpen, Belgium, 2060
AZ Sint Lucas Brugge
Brugge, Belgium, 8310
UZ Antwerpen #2
Edegem, Belgium, 2650
Genk, Belgium, 3600
AZ Maria Middelares
Gent, Belgium, 9000
UZ Gent
Gent, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
CHC Cliniques Saint Joseph
Liège, Belgium, 4000
CHU A. Vesale
Montigny-le-Tilleul, Belgium, 6110
AZ Sint-Augustinus
Wilrijk, Belgium, 2610
Sponsors and Collaborators
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Study Director: Ipsen Medical Director Ipsen
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ipsen Identifier: NCT00891371    
Other Study ID Numbers: I-48-52030-223
2009-009356-20 ( EudraCT Number )
First Posted: May 1, 2009    Key Record Dates
Results First Posted: September 29, 2015
Last Update Posted: January 15, 2019
Last Verified: January 2019
Keywords provided by Ipsen:
symptomatic treatment of patients with refractory diarrhea
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms
Antineoplastic Agents