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

NCT00729313 | Completed Phase 3

• 1 other identifier: E-54-52030-053
• Study Type: interventional
• Target: 111
• Locations: 2 countries
• Sites: 19

Brief Summary

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

Conditions

Digestive Fistulae

Keywords

Treatment

Outcome Measures

Primary Outcomes (1)

• Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours.

  Fistula drainage volume on 3rd day.

Secondary Outcomes (5)

• 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.

  Day 60

• Pancreatic or duodenal and small intestine fistula closing rate within D60

  Day 60

• Number of injections received by each patient

  End of study

• Percentage of fistula recurrence during the follow-up period

  Duration of follow-up period for each patient is of 1 month

• Percentage of mortality in each group

  End of study

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

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

Interventions

Lanreotide microparticles DRUG

1

Placebo DRUG

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (19)

Hôpital Nord

Amiens, 80054, France

Location

CHU J. Minjoz

Besançon, 25031, France

Location

Hôpital Avicenne

Bobigny, 93009, France

Location

Hôpital de la Cavale Blanche

Brest, 29609, France

Location

Hôpital Louis Mourier

Colombes, 92700, France

Location

Hôpital Henri Mondor

Créteil, 94000, France

Location

Hôpital A. Michallon

Grenoble, 38043, France

Location

CHU de Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Hotel Dieu

Lyon, 69288, France

Location

Hôpital Nord

Marseille, 13915, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Hôpital de Hautepierre

Strasbourg, 67098, France

Location

Hôpital Trousseau

Tours, 37044, France

Location

Hôpital de Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Institute of Surgery n.a. A.V. Vishnevsky

Moscow, 113811, Russia

Location

National Research Centre of Surgery

Moscow, 119992, Russia

Location

Related Publications (1)

• Gayral F, Campion JP, Regimbeau JM, Blumberg J, Maisonobe P, Topart P, Wind P; Lanreotide Digestive Fistula. Randomized, placebo-controlled, double-blind study of the efficacy of lanreotide 30 mg PR in the treatment of pancreatic and enterocutaneous fistulae. Ann Surg. 2009 Dec;250(6):872-7. doi: 10.1097/sla.0b013e3181b2489f.

  PMID: 19953707 RESULT

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: August 7, 2008
• Study Start: April 1, 2000
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: March 4, 2019

Record last verified: 2019-03

Locations

FR (17); RU (2)