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Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study

NCT02354768 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-03-07

No results posted yet for this study

Summary

Dehydration is a major problem of high output stoma with a 17% rate of readmission at 30 days. Dehydratations are resulting of significant electrolyte loss: sodium, potassium and renal failure. Nowadays, there are no recommendations nor national nor international for high output ileostomy treatment. Apart from the anti-diarrhea treatments used in current practice, somatostatin analogs have proven efficacy in the literature. Theses analogs permit to decrease significantly gastrointestinal secretions. Several teams use these analogs in order to decrease the flow of highly productive ileostomy.

The aim of the study is to evaluate the efficacy first line treatment with lanreotide associated with current anti-diarrheal treatment for patients with high output ileostomy (or greater throughput 1.5l / 24h) with or without associated dehydration

Conditions

  • High Output Stoma

Interventions

DRUG

Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide)

DRUG

Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone

Sponsors & Collaborators

  • Ipsen

    collaborator INDUSTRY

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Benoit ROMAIN, MD · Hôpitaux Universitaires de Strasbourg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-22
Primary Completion
2017-12-31
Completion
2018-01-26

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02354768 on ClinicalTrials.gov