Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

Diarrhea Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891371
• Other study ID #: I-48-52030-223
• Secondary ID: 2009-009356-20
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2009
• Est. completion date: August 2013

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diarrhea

Intervention

Drug:
• lanreotide (Autogel formulation)
Autogel 120mg

Locations

Country	Name	City	State
Belgium	OLVZ Aalst	Aalst
Belgium	ZNA Antwerpen	Antwerpen
Belgium	AZ Sint Lucas Brugge	Brugge
Belgium	UZ Antwerpen #2	Edegem
Belgium	ZOL	Genk
Belgium	AZ Maria Middelares	Gent
Belgium	UZ Gent	Gent
Belgium	UZ Leuven	Leuven
Belgium	CHC Cliniques Saint Joseph	Liège
Belgium	CHU A. Vesale	Montigny-le-Tilleul
Belgium	AZ Sint-Augustinus	Wilrijk

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56
Secondary	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	Baseline (day 1), day 28 and day 56
Secondary	Percent Change in Mean Number of Stools Compared to Baseline		Baseline (Day 1), Day 28 and Day 56
Secondary	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.	Baseline (Day 1), Day 28 and Day 56
Secondary	Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools		Day 56