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

This study has been completed.
Information provided by (Responsible Party):
Ipsen Identifier:
First received: April 30, 2009
Last updated: August 28, 2015
Last verified: August 2015

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 Intervention Phase
Drug: lanreotide (Autogel formulation)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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

  • Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline [ Time Frame: Baseline (day 1), day 28 and day 56 ] [ Designated as safety issue: No ]
    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

  • Percent Change in Mean Number of Stools Compared to Baseline [ Time Frame: Baseline (Day 1), Day 28 and Day 56 ] [ Designated as safety issue: No ]
  • Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects [ Time Frame: Baseline (Day 1), Day 28 and Day 56 ] [ Designated as safety issue: No ]
    Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline.

  • Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools [ Time Frame: Day 56 ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: July 2009
Study Completion Date: August 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lanreotide (Autogel formulation) Autogel 120mg
lanreotide (Autogel formulation) Autogel 120mg
Drug: lanreotide (Autogel formulation)
Autogel 120mg


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00891371

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
Study Director: Eugène Vissers, MD Ipsen
  More Information

No publications provided

Responsible Party: Ipsen Identifier: NCT00891371     History of Changes
Other Study ID Numbers: I-48-52030-223, 2009-009356-20
Study First Received: April 30, 2009
Results First Received: July 17, 2015
Last Updated: August 28, 2015
Health Authority: Belgium: Institutional Review Board

Keywords provided by Ipsen:
symptomatic treatment of patients with refractory diarrhea

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive
Antineoplastic Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses processed this record on October 13, 2015