Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae
This study has been completed.
Sponsor:
Ipsen
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00729313
First received: August 4, 2008
Last updated: June 18, 2012
Last verified: June 2012
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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
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 | |
| Hotel Dieu | |
| Lyon, France, 69288 | |
| Hôpital Edouard Herriot | |
| Lyon, France, 69003 | |
| 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 | |
| National Research Centre of Surgery | |
| Moscow, Russian Federation, 119992 | |
| Institute of Surgery n.a. A.V. Vishnevsky | |
| Moscow, Russian Federation, 113811 | |
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 Lanreotide Angiopeptin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013