Clinical trial NCT00891371: Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea
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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diarrhea
Keywords: symptomatic treatment of patients with refractory diarrhea
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2009-05-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days)
timeFrame: Day 28
Secondary outcomes:
measure: Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline
timeFrame: Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56
measure: Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline
timeFrame: Baseline (day 1), day 28 and day 56
measure: Percent Change in Mean Number of Stools Compared to Baseline
timeFrame: Baseline (Day 1), Day 28 and Day 56
measure: Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects
timeFrame: Baseline (Day 1), Day 28 and Day 56
measure: Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools
timeFrame: Day 56
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLVZ Aalst
city: Antwerpen
country: Belgium
facility: ZNA Antwerpen
city: Brugge
country: Belgium
facility: AZ Sint Lucas Brugge
city: Edegem
country: Belgium
facility: UZ Antwerpen #2
city: Genk
country: Belgium
facility: ZOL
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHC Cliniques Saint Joseph
city: Montigny-le-Tilleul
country: Belgium
facility: CHU A. Vesale
city: Wilrijk
country: Belgium
facility: AZ Sint-Augustinus
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
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.