Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea (MEDARD)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Ipsen

ClinicalTrials.gov Identifier:

NCT00891371

First received: April 30, 2009

Last updated: March 31, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 30, 2009

Last Updated Date

March 31, 2013

Start Date ^ICMJE

July 2009

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of patients having minimum reduction of 50% or normalization (≤3stools/24hours) in the mean number of stools [ Time Frame: recorded during the seven day period immediately prior to Day28 or early termination, compared to the mean of seven day period prior to baseline visit ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00891371 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

change in QOL-Quality of Life {assess using Short Form (SF-36) and Irritable Bowel Syndrome (IBS-QOL)} compared to baseline [ Time Frame: at day 21, 28, 49 & 56 ] [ Designated as safety issue: No ]
change in median score of stool consistency (Bristol stool Form Scale) [ Time Frame: recorded during the seven day period immediately prior to Day28, and Day56 or early termination compared to the mean of seven day period prior to baseline visit ] [ Designated as safety issue: No ]
percent change in mean number of stools [ Time Frame: recorded during the seven day period before day28 and day56 compared to the mean of seven day period to baseline visit ] [ Designated as safety issue: No ]
percentage of normalized subjects (=subjects with ≤3 stools per 24 hours) [ Time Frame: at day21, day28, day49 and day56 or at early termination visit (according to the seven day period before each considered assessment) ] [ Designated as safety issue: No ]
minimum reduction of 50% or normalization (≤3 stools per 24 hours) in the mean number of stools [ Time Frame: recorded during the seven day period immediately prior to day49 or early termination compared to the mean of seven day period to baseline visit ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diarrhea

Intervention ^ICMJE

Drug: lanreotide (Autogel formulation)

Autogel 120mg

Study Arm (s)

Experimental: lanreotide (Autogel formulation) Autogel 120mg

lanreotide (Autogel formulation) Autogel 120mg

Intervention: Drug: lanreotide (Autogel formulation)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

May 2013

Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT00891371

Other Study ID Numbers ^ICMJE

I-48-52030-223, 2009-009356-20

Has Data Monitoring Committee

Responsible Party

Ipsen

Study Sponsor ^ICMJE

Ipsen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Eugène Vissers, MD

Ipsen

Information Provided By

Ipsen

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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