Status
Completed
Phase
Phase 3
Enrollment
80
Locations
53
Results
Not posted
Publications
1
Study summary
The purpose of this study is to determine whether lanreotide 30mg microparticles are effective in the relief of clinical symptoms due to small bowel obstruction in inoperable patients with peritoneal carcinomatosis.
Interventions
DRUG
A single 30 mg intra-muscular injection on day 0. The duration of the blinded phase is 10 days. Patients may enter the open phase where they receive 30 mg intra-muscular injections, every 10 days until investigator/or patient decide to stop treatment.
OTHER
A single intra-muscular injection on day 0.
Timeline
First posted
Sep 22, 2005
Study start
Sep 2003
Primary completion
Oct 2008
Study completion
Oct 2008
Results posted
Not reported
Registry updated
Nov 5, 2020
Outcomes
Percentage of responder patients (patient with 1 or less vomiting episode per day during at least 3 consecutive days or in whom nasogastric tube (NGT) has been removed during at least three consecutive days without vomiting recurrence)
Time frame · On day 7 (plus 1 day at the latest) after the first injection
Number of daily vomiting episodes or measurement of the daily drainage by NGT
Time frame · Daily for the duration of the study
Number of days with no vomiting episodes
Time frame · For the duration of the study
Number of daily nausea episodes
Time frame · Daily for the duration of the study
Intensity of abdominal pain
Time frame · Daily for the duration of the study
Well-being
Time frame · Daily for the duration of the study
Symptom relief duration
Time frame · Between the first day of clinical response and the end of follow-up
Eligibility
Inclusion Criteria: * digestive obstruction located in the upper part of the gastro-intestinal tract * digestive obstruction of malignant origin * peritoneal carcinomatosis confirmed by a CT Scan * at least two vomiting episodes per day or a presence of a nasogastric suction tube * inoperable patients Exclusion Criteria: * specific anticancer therapy within the previous 15 days * signs of bowel perforation * somatostatin or any analogue as treatment of the bowel obstruction
Study locations
Belgium · France · Netherlands. Showing up to 24 locations stored in the fast local snapshot.
Clinique Universitaire St. LUC
Brussels, Belgium
Institut Jules Bordet
Brussels, Belgium
Clinique Notre-Dame
Hermalle-sous-Huy, Belgium
Centre Hospitalier de Jolimont-Lobbes
La Louvière, Belgium
Hôpital Nord
Amiens, France
Clinique de l'Anjou
Angers, France
Hôtel-Dieu
Angers, France
CH Victor Dupouy
Argenteuil, France
Hôpital Saint André
Bordeaux, France
Hôpital de la Cavale Blanche
Brest, France
Centre François Baclesse
Caen, France
Hôpital Nord
Cébazat, France
Clinique de l'Amandier
Châtenay-Malabry, France
Hôpital Hôtel-Dieu
Clermont-Ferrand, France
Hôpital Beaujon
Clichy, France
Hôpital Pasteur
Colmar, France
Centre Hospitalier de Compiègne
Compiègne, France
Hôpital Henri Mondor
Créteil, France
Centre Hospitalier Victor Jousselin
Dreux, France
Clinique Sainte Marguerite
Hyères, France
Centre Hospitalier Départemental
La Roche-sur-Yon, France
Hôpital André Mignot
Le Chesnay, France
Hôpital Notre-Dame du Perpétuel Secours
Levallois-Perret, France
CHU Dupuytren
Limoges, France
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