- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00891371
Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea (MEDARD)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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