Skip to content

Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

Short name MEDARD

NCTNCT00891371 (opens ClinicalTrials.gov in a new tab)Other idI-48-52030-223Other id2009-009356-20Other id2009
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
42 participants (actual)
Sponsor
Ipsen · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Belgium

Start
Jul 2009
Primary completion
Aug 2012
Completion
Aug 2013
First posted
1 May 2009 (estimated)
Last update posted
15 Jan 2019
Conditions
Diarrhea

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011201220132014
  1. Ph 2/3

    MEDARD

    NCT00891371

    Jul 2009 to Aug 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • lanreotide (Autogel formulation)Drug

Arms1

  • Experimental

    lanreotide (Autogel formulation) Autogel 120mg

    lanreotide (Autogel formulation) Autogel 120mg

Primary outcomes1

Outcomes the sponsor listed as primary.

  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(5)

  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

    Registry description

    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

    Registry description

    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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Day 28

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

GroupValue (Percentage of patients)
Lanreotide Autogel 120 mg44.4
Secondary and other outcome results(5)
Secondary outcomeMean· Baseline (Day 1), Day 21, Day 28, Day 49 and Day 56

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

GroupValue (units on a scale)Spread
Lanreotide Autogel 120 mg-1.320.5
Secondary outcomeMedian· Baseline (day 1), day 28 and day 56

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

GroupValue (units on a scale)
Lanreotide Autogel 120 mg0.0
Secondary outcomeMean· Baseline (Day 1), Day 28 and Day 56

Percent Change in Mean Number of Stools Compared to Baseline

GroupValue (Percent change)Spread
Lanreotide Autogel 120 mg-25.936.7
Secondary outcomeMean· Baseline (Day 1), Day 28 and Day 56

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

GroupValue (Percentage of days per Week)Spread
Lanreotide Autogel 120 mg27.534.7
Secondary outcomeNumber· Day 56

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

GroupValue (Percentage of participants)
Lanreotide Autogel 120 mg54.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Lanreotide Autogel 120 mgLanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28–5 / 3630 / 36

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2016

Lanreotide Autogel in the Treatment of Idiopathic Refractory Diarrhea: Results of an Exploratory, Controlled, Before and After, Open-label, Multicenter, Prospective Clinical Trial.

Bisschops et al. 2016Clinical therapeuticscited by 11

PMID 27423779DOI 10.1016/j.clinthera.2016.06.012PUB-27423779

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

PepBank is a research reference. Talk to a doctor before you use any peptide.