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Sponsored by: |
Ipsen |
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Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00729313 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
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 |
---|---|
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 |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
CHU de Bicêtre | |
Kremlin Bicêtre, France, 94275 | |
Hôpital de Brabois | |
Vandoeuvre les Nancy, France, 54500 | |
Hôpital Louis Mourier | |
Colombes, France, 92700 | |
Hôpital Trousseau | |
Tours, France, 37044 | |
Hôpital Pontchaillou | |
Rennes, France, 35033 | |
Hôpital de la Cavale Blanche | |
Brest, France, 29609 | |
Hotel Dieu | |
Lyon, France, 69288 | |
Hôpital Nord | |
Marseille, France, 13915 | |
Hôpital de Hautepierre | |
Strasbourg, France, 67098 | |
CHU J. Minjoz | |
Besançon, France, 25031 | |
Hôpital Avicenne | |
Bobigny, France, 93009 | |
Hôpital Henri Mondor | |
Créteil, France, 94000 | |
Hôpital A. Michallon | |
Grenoble, France, 38043 | |
Hôpital Lariboisière | |
Paris, France, 75010 | |
Groupe Hospitalier Pitié-Salpêtrière | |
Paris, France, 75013 | |
Hôpital Nord | |
Amiens, France, 80054 | |
Hôpital Edouard Herriot | |
Lyon, France, 69003 | |
Russian Federation | |
National Research Centre of Surgery | |
Moscow, Russian Federation, 119992 | |
Institute of Surgery n.a. A.V. Vishnevsky | |
Moscow, Russian Federation, 113811 |
Study Director: | Joëlle Blumberg, MD | Ipsen |
Responsible Party: | Ipsen ( Joelle Blumberg ) |
Study ID Numbers: | E-54-52030-053 |
Study First Received: | August 4, 2008 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00729313 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Treatment |
Pathological Conditions, Anatomical Lanreotide Angiopeptin Fistula |
Antineoplastic Agents Therapeutic Uses Cardiovascular Agents Pharmacologic Actions |