Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae
NCT ID: NCT00729313
Last Updated: 2019-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
111 participants
INTERVENTIONAL
2000-04-30
2005-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Lanreotide microparticles
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.
Placebo
Interventions
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Lanreotide microparticles
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
80 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Ipsen
Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Hôpital Nord
Amiens, , France
CHU J. Minjoz
Besançon, , France
Hôpital Avicenne
Bobigny, , France
Hôpital de la Cavale Blanche
Brest, , France
Hôpital Louis Mourier
Colombes, , France
Hôpital Henri Mondor
Créteil, , France
Hôpital A. Michallon
Grenoble, , France
CHU de Bicêtre
Le Kremlin-Bicêtre, , France
Hôpital Edouard Herriot
Lyon, , France
Hotel Dieu
Lyon, , France
Hôpital Nord
Marseille, , France
Hôpital Lariboisière
Paris, , France
Groupe Hospitalier Pitié-Salpêtrière
Paris, , France
Hôpital Pontchaillou
Rennes, , France
Hôpital de Hautepierre
Strasbourg, , France
Hôpital Trousseau
Tours, , France
Hôpital de Brabois
Vandœuvre-lès-Nancy, , France
Institute of Surgery n.a. A.V. Vishnevsky
Moscow, , Russia
National Research Centre of Surgery
Moscow, , Russia
Countries
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References
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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.
Other Identifiers
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E-54-52030-053
Identifier Type: -
Identifier Source: org_study_id
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