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

Primary Purpose

Diarrhea

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
lanreotide (Autogel formulation)
Sponsored by
Ipsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring symptomatic treatment of patients with refractory diarrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • OLVZ Aalst
  • ZNA Antwerpen
  • AZ Sint Lucas Brugge
  • UZ Antwerpen #2
  • ZOL
  • AZ Maria Middelares
  • UZ Gent
  • UZ Leuven
  • CHC Cliniques Saint Joseph
  • CHU A. Vesale
  • AZ Sint-Augustinus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lanreotide (Autogel formulation) Autogel 120mg

Arm Description

lanreotide (Autogel formulation) Autogel 120mg

Outcomes

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)

Secondary Outcome Measures

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
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
Percent Change in Mean Number of Stools Compared to Baseline
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.
Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools

Full Information

First Posted
April 30, 2009
Last Updated
January 11, 2019
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00891371
Brief Title
Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea
Acronym
MEDARD
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 Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
Keywords
symptomatic treatment of patients with refractory diarrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lanreotide (Autogel formulation) Autogel 120mg
Arm Type
Experimental
Arm Description
lanreotide (Autogel formulation) Autogel 120mg
Intervention Type
Drug
Intervention Name(s)
lanreotide (Autogel formulation)
Intervention Description
Autogel 120mg
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
Description
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
Time Frame
Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56
Title
Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline
Description
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
Time Frame
Baseline (day 1), day 28 and day 56
Title
Percent Change in Mean Number of Stools Compared to Baseline
Time Frame
Baseline (Day 1), Day 28 and Day 56
Title
Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects
Description
Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline.
Time Frame
Baseline (Day 1), Day 28 and Day 56
Title
Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools
Time Frame
Day 56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
OLVZ Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
ZNA Antwerpen
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
AZ Sint Lucas Brugge
City
Brugge
ZIP/Postal Code
8310
Country
Belgium
Facility Name
UZ Antwerpen #2
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
ZOL
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
AZ Maria Middelares
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHC Cliniques Saint Joseph
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU A. Vesale
City
Montigny-le-Tilleul
ZIP/Postal Code
6110
Country
Belgium
Facility Name
AZ Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
27423779
Citation
Bisschops R, De Ruyter V, Demolin G, Baert D, Moreels T, Pattyn P, Verhelst H, Lepoutre L, Arts J, Caenepeel P, Ooghe P, Codden T, Maisonobe P, Petrens E, Tack J. Lanreotide Autogel in the Treatment of Idiopathic Refractory Diarrhea: Results of an Exploratory, Controlled, Before and After, Open-label, Multicenter, Prospective Clinical Trial. Clin Ther. 2016 Aug;38(8):1902-1911.e2. doi: 10.1016/j.clinthera.2016.06.012. Epub 2016 Aug 8.
Results Reference
derived

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Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

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