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Completed

NCT Number: NCT00891371

Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

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.

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Key information

Conditions

Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

OLVZ Aalst, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lanreotide (Autogel formulation)

Drug

Autogel 120mg

Primary outcomes

  1. Percentage of Patients Having Minimum Reduction of 50% or Normalization (≤3 Stools/24hours) in the Mean Number of Stools (Mean of Last 7 Days)

    Time frame: Day 28

Secondary outcomes

  1. Change in QOL-Quality of Life {Assess Using Short Form (SF-36) and Irritable Bowel Syndrome (IBS)-QOL} Compared to Baseline

    Time frame: Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56

    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

  2. Change in Median Score of Stool Consistency (Bristol Stool Form Scale) Compared to Baseline

    Time frame: Baseline (day 1), day 28 and day 56

    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

  3. Percent Change in Mean Number of Stools Compared to Baseline

    Time frame: Baseline (Day 1), Day 28 and Day 56

  4. Change From Baseline in Relative Frequency of Normalization (≤3 Stools) in Subjects

    Time frame: Baseline (Day 1), Day 28 and Day 56

    Normalization of stool frequency in subjects with refractory diarrhoea at Day 28 and Day 56 (mean of last 7 days) compared to Baseline.

  5. Percentage of Patients Having Minimum Reduction of At Least 50% or Normalization of the Mean Number of Stools

    Time frame: Day 56

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Acronym: MEDARD

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
May 1, 2009
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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