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DiarrheaPhase 2/3MEDARDNCT00891371

Lanreotide Autogel in the Symptomatic Treatment of Refractory Diarrhea

A Phase 2/3 study testing lanreotide (Autogel formulation) in people with Diarrhea, run by Ipsen at 11 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diarrhea
What is being tested?
lanreotide (Autogel formulation)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
11 sitesBelgium
Study dates
Jul 2009to Aug 2013
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Belgium11 sites

  • OLVZ Aalst

    Aalst, 9300

  • ZNA Antwerpen

    Antwerp, 2060

  • AZ Sint Lucas Brugge

    Bruges, 8310

  • UZ Antwerpen #2

    Edegem, 2650

  • ZOL

    Genk, 3600

  • AZ Maria Middelares

    Ghent, 9000

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • CHC Cliniques Saint Joseph

    Liège, 4000

  • CHU A. Vesale

    Montigny-le-Tilleul, 6110

  • AZ Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

About this study

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

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.

Conditions
Diarrhea
Being tested
lanreotide (Autogel formulation)
Keywords
symptomatic treatment of patients with refractory diarrhea
Medical subject headings
Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lanreotide (Autogel formulation)Drug

    Autogel 120mg

Study groups in NCT00891371
Study groupRoleWhat they receive
lanreotide (Autogel formulation) Autogel 120mgExperimentallanreotide (Autogel formulation) Autogel 120mg
Receives: Drug: lanreotide (Autogel formulation)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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

    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

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

  2. 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

    Measured: Baseline (day 1), day 28 and day 56

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

    Measured: Baseline (Day 1), Day 28 and Day 56

  4. 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.

    Measured: Baseline (Day 1), Day 28 and Day 56

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

    Measured: Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionAug 2012
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00891371
Sponsor's protocol ID
I-48-52030-223
Other IDs
2009-009356-20, 2009
Acronym
MEDARD
Status last verified
Jan 2019
First submitted
30 Apr 2009
Last updated
15 Jan 2019
Data monitoring committee
No

Publications

  • Bisschops R, De Ruyter V, Demolin G, Baert D, Moreels T, Pattyn P, Verhelst H, Lepoutre L, Arts J, Caenepeel P, Ooghe P, Codden T, Maisonobe P, Petrens E, Tack J. Lanreotide Autogel in the Treatment of Idiopathic Refractory Diarrhea: Results of an Exploratory, Controlled, Before and After, Open-label, Multicenter, Prospective Clinical Trial. Clin Ther. 2016 Aug;38(8):1902-1911.e2. doi: 10.1016/j.clinthera.2016.06.012. Epub 2016 Aug 8.

    PubMed 27423779

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing lanreotide (Autogel formulation) in people with Diarrhea, run by Ipsen at 11 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00891371, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.

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