Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae

March 1, 2019 updated by: Ipsen

A Phase III Multicentre Randomised Double-blind Comparative Study of Efficacy and Safety of Lanreotide 30 mg Versus Placebo for Treatment of Patients With Digestive Fistulae

The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine whether lanreotide 30mg compared to placebo is effective on the evolution of drainage volume of digestive fistulae in the 72 hours following the beginning of treatment and on the spontaneous closure time of digestive fistulae.

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • Hopital Nord
      • Besançon, France, 25031
        • CHU J. Minjoz
      • Bobigny, France, 93009
        • Hôpital Avicenne
      • Brest, France, 29609
        • Hopital De La Cavale Blanche
      • Colombes, France, 92700
        • Hopital Louis Mourier
      • Créteil, France, 94000
        • Hopital Henri Mondor
      • Grenoble, France, 38043
        • Hôpital A. MICHALLON
      • Kremlin Bicêtre, France, 94275
        • CHU de Bicêtre
      • Lyon, France, 69003
        • Hôpital Edouard Herriot
      • Lyon, France, 69288
        • Hotel Dieu
      • Marseille, France, 13915
        • Hopital Nord
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Paris, France, 75013
        • Groupe Hospitalier Pitie-Salpetriere
      • Rennes, France, 35033
        • Hopital Pontchaillou
      • Strasbourg, France, 67098
        • Hôpital de HAUTEPIERRE
      • Tours, France, 37044
        • Hopital Trousseau
      • Vandoeuvre les Nancy, France, 54500
        • Hôpital de Brabois
  • Russian Federation
      • Moscow, Russian Federation, 119992
        • National Research Centre of Surgery
      • Moscow, Russian Federation, 113811
        • Institute of Surgery n.a. A.V. Vishnevsky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with pancreatic, duodenal, or small intestine fistula
  • Patient with simple, externalised fistula
  • Patient with fistula for which a medical conservative treatment is considered
  • Patient with:
  • for pancreatic fistulae: a mean drainage volume more than or equal to 100 ml/24h over 48 hours or more than or equal to 50 ml / 24h over 3 days and a concentration of amylase in the drainage fluid 3 times higher than in the serum over at least 2 or 3 consecutive days respectively,
  • for duodenal and small intestine fistulae: a mean drainage volume more than or equal to 100ml/24h over 2 days

Exclusion Criteria:

  • Patient expected to require a surgical treatment of the fistula during the study
  • Patient having uncontrolled intra-abdominal sepsis; Crohn's disease; radiotherapy lesions of the small bowel; a mesenteric vascular insufficiency; a fistula localised in cancer-infiltrated areas; a distal obstruction; an exposed fistula of the small intestine; or intra-abdominal foreign bodies.
  • Patient receiving long-term corticotherapy
  • Patient having received any somatostatin analogue as curative treatment of the fistula or any PRF somatostatin analogue within the previous month.
  • Patient having previously undergone a transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1

Drug: Lanreotide 30 mg microparticle formulation

One intra-muscular injection.

A (maximum) 60 day "treatment" period (6 intra-muscular injections of lanreotide 30 mg microparticle formulation every 10 days): according to the patient's treatment response at 72h

For non-responders patients lanreotide will be stopped.
Drug: Lanreotide microparticles
Placebo Comparator: 2

One intra-muscular injection.

A (maximum) 60 day "treatment" period (6 intra-muscular injections of placebo every 10 days): according to the patient's treatment response at 72h.

Non-responder patients having received placebo on the first injection should receive an open-labelled lanreotide treatment.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours.
Time Frame: Fistula drainage volume on 3rd day.
Fistula drainage volume on 3rd day.

Secondary Outcome Measures

Outcome Measure
Time Frame
Closure time of digestive fistulae will be defined by the interval between D0 (day of the first injection) and the date of spontaneous closure of the fistula.
Time Frame: Day 60
Day 60
Pancreatic or duodenal and small intestine fistula closing rate within D60
Time Frame: Day 60
Day 60
Number of injections received by each patient
Time Frame: End of study
End of study
Percentage of fistula recurrence during the follow-up period
Time Frame: Duration of follow-up period for each patient is of 1 month
Duration of follow-up period for each patient is of 1 month
Percentage of mortality in each group
Time Frame: End of study
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

August 4, 2008

First Submitted That Met QC Criteria

August 6, 2008

First Posted (Estimate)

August 7, 2008

Study Record Updates

Last Update Posted (Actual)

March 4, 2019

Last Update Submitted That Met QC Criteria

March 1, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-54-52030-053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Digestive Fistulae

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe