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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00729313
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : June 19, 2012
Information provided by:

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

Condition or disease Intervention/treatment Phase
Digestive Fistulae Drug: Lanreotide microparticles Drug: Placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2000
Primary Completion Date : April 2005
Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

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

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

Secondary Outcome Measures :
  1. 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 ]
  2. Pancreatic or duodenal and small intestine fistula closing rate within D60 [ Time Frame: Day 60 ]
  3. Number of injections received by each patient [ Time Frame: End of study ]
  4. Percentage of fistula recurrence during the follow-up period [ Time Frame: Duration of follow-up period for each patient is of 1 month ]
  5. Percentage of mortality in each group [ Time Frame: End of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729313

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
Study Director: Joëlle Blumberg, MD Ipsen

Responsible Party: Joelle Blumberg, Ipsen
ClinicalTrials.gov Identifier: NCT00729313     History of Changes
Other Study ID Numbers: E-54-52030-053
First Posted: August 7, 2008    Key Record Dates
Last Update Posted: June 19, 2012
Last Verified: June 2012

Keywords provided by Ipsen:

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs