Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea
- Registration Number
- NCT00891371
- Lead Sponsor
- Ipsen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description lanreotide (Autogel formulation) Autogel 120mg lanreotide (Autogel formulation) lanreotide (Autogel formulation) Autogel 120mg
- Primary Outcome Measures
Name Time Method Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days) Day 28
- Secondary Outcome Measures
Name Time Method Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline 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 QOLPercent Change in Mean Number of Stools 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 Day 56 Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline 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
Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects 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.
Trial Locations
- Locations (11)
OLVZ Aalst
🇧🇪Aalst, Belgium
AZ Maria Middelares
🇧🇪Gent, Belgium
AZ Sint-Augustinus
🇧🇪Wilrijk, Belgium
AZ Sint Lucas Brugge
🇧🇪Brugge, Belgium
UZ Antwerpen #2
🇧🇪Edegem, Belgium
CHC Cliniques Saint Joseph
🇧🇪Liège, Belgium
ZOL
🇧🇪Genk, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
ZNA Antwerpen
🇧🇪Antwerpen, Belgium
UZ Gent
🇧🇪Gent, Belgium
CHU A. Vesale
🇧🇪Montigny-le-Tilleul, Belgium