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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
  Purpose

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.


Condition Intervention Phase
Diarrhea
 Drug: lanreotide (Autogel formulation)
 Phase 2
Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: July 2009
Estimated Study Completion Date: May 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lanreotide (Autogel formulation) Autogel 120mg
lanreotide (Autogel formulation) Autogel 120mg
 Drug: lanreotide (Autogel formulation)
Autogel 120mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891371

Locations
Belgium
OLVZ Aalst
Aalst, Belgium, 9300
ZNA Antwerpen
Antwerpen, Belgium, 2060
AZ Sint Lucas Brugge
Brugge, Belgium, 8310
UZ Antwerpen #2
Edegem, Belgium, 2650
ZOL
Genk, Belgium, 3600
AZ Maria Middelares
Gent, Belgium, 9000
UZ Gent
Gent, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
CHC Cliniques Saint Joseph
Liège, Belgium, 4000
CHU A. Vesale
Montigny-le-Tilleul, Belgium, 6110
AZ Sint-Augustinus
Wilrijk, Belgium, 2610
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Eugène Vissers, MD Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00891371     History of Changes
Other Study ID Numbers: I-48-52030-223, 2009-009356-20
Study First Received: April 30, 2009
Last Updated: March 31, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by Ipsen:
symptomatic treatment of patients with refractory diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Lanreotide
Angiopeptin
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013