Status:
COMPLETED
Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea
Lead Sponsor:
Ipsen
Conditions:
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00891371
Start Date
July 1 2009
End Date
August 1 2013
Last Update
January 15 2019
Active Locations (11)
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1
OLVZ Aalst
Aalst, Belgium, 9300
2
ZNA Antwerpen
Antwerp, Belgium, 2060
3
AZ Sint Lucas Brugge
Bruges, Belgium, 8310
4
UZ Antwerpen #2
Edegem, Belgium, 2650