Back to resultsEfficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae
Primary Purpose
Digestive Fistulae
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lanreotide microparticles
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Digestive Fistulae focused on measuring Treatment
Eligibility 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
Sites / Locations
- Hôpital Nord
- CHU J. Minjoz
- Hôpital Avicenne
- Hôpital de la Cavale Blanche
- Hôpital Louis Mourier
- Hôpital Henri Mondor
- Hôpital A. Michallon
- CHU de Bicêtre
- Hôpital Edouard Herriot
- Hotel Dieu
- Hôpital Nord
- Hôpital Lariboisière
- Groupe Hospitalier Pitié-Salpêtrière
- Hôpital Pontchaillou
- Hôpital de Hautepierre
- Hôpital Trousseau
- Hôpital de Brabois
- Institute of Surgery n.a. A.V. Vishnevsky
- National Research Centre of Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours.
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.
Pancreatic or duodenal and small intestine fistula closing rate within D60
Number of injections received by each patient
Percentage of fistula recurrence during the follow-up period
Percentage of mortality in each group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00729313
Brief Title
Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae
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 Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ipsen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive Fistulae
Keywords
Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lanreotide microparticles
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Pancreatic or duodenal and small intestine fistula closing rate within D60
Time Frame
Day 60
Title
Number of injections received by each patient
Time Frame
End of study
Title
Percentage of fistula recurrence during the follow-up period
Time Frame
Duration of follow-up period for each patient is of 1 month
Title
Percentage of mortality in each group
Time Frame
End of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Nord
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU J. Minjoz
City
Besançon
ZIP/Postal Code
25031
Country
France
Facility Name
Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Hôpital de la Cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Hôpital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Hôpital A. Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHU de Bicêtre
City
Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Hotel Dieu
City
Lyon
ZIP/Postal Code
69288
Country
France
Facility Name
Hôpital Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Groupe Hospitalier Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hôpital Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Hôpital de Brabois
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Institute of Surgery n.a. A.V. Vishnevsky
City
Moscow
ZIP/Postal Code
113811
Country
Russian Federation
Facility Name
National Research Centre of Surgery
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
19953707
Citation
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.
Results Reference
result
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Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae
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