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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00729313
First received: August 4, 2008
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Digestive Fistulae
Drug: Lanreotide microparticles
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours. [ Time Frame: Fistula drainage volume on 3rd day. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Pancreatic or duodenal and small intestine fistula closing rate within D60 [ Time Frame: Day 60 ] [ Designated as safety issue: No ]
  • Number of injections received by each patient [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Percentage of fistula recurrence during the follow-up period [ Time Frame: Duration of follow-up period for each patient is of 1 month ] [ Designated as safety issue: No ]
  • Percentage of mortality in each group [ Time Frame: End of study ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: April 2000
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729313

Locations
France
Hôpital Nord
Amiens, France, 80054
CHU J. Minjoz
Besançon, France, 25031
Hôpital Avicenne
Bobigny, France, 93009
Hôpital de la Cavale Blanche
Brest, France, 29609
Hôpital Louis Mourier
Colombes, France, 92700
Hôpital Henri Mondor
Créteil, France, 94000
Hôpital A. Michallon
Grenoble, France, 38043
CHU de Bicêtre
Kremlin Bicêtre, France, 94275
Hôpital Edouard Herriot
Lyon, France, 69003
Hotel Dieu
Lyon, France, 69288
Hôpital Nord
Marseille, France, 13915
Hôpital Lariboisière
Paris, France, 75010
Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013
Hôpital Pontchaillou
Rennes, France, 35033
Hôpital de Hautepierre
Strasbourg, France, 67098
Hôpital Trousseau
Tours, France, 37044
Hôpital de Brabois
Vandoeuvre les Nancy, France, 54500
Russian Federation
Institute of Surgery n.a. A.V. Vishnevsky
Moscow, Russian Federation, 113811
National Research Centre of Surgery
Moscow, Russian Federation, 119992
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Joëlle Blumberg, MD Ipsen
  More Information

Publications:
Responsible Party: Joelle Blumberg, Ipsen
ClinicalTrials.gov Identifier: NCT00729313     History of Changes
Other Study ID Numbers: E-54-52030-053
Study First Received: August 4, 2008
Last Updated: June 18, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Ipsen:
Treatment

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical
Angiopeptin
Lanreotide
Antineoplastic Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014