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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00216372
Other study ID # 2-54-52030-156 (408)
Secondary ID 2005-002349-38
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2003
Est. completion date October 2008

Study information

Verified date November 2020
Source Ipsen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Lanreotide (microparticle formulation)
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:
Placebo
A single intra-muscular injection on day 0.

Locations

Country Name City State
Belgium Clinique Universitaire St. LUC Bruxelles
Belgium Institut Jules Bordet Bruxelles
Belgium Clinique Notre-Dame Hermalle-sous-Huy
Belgium Centre Hospitalier de Jolimont-Lobbes La Louvière
France 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 Cebazat
France Clinique de l'Amandier Chatenay-Malabry
France Hôpital Hôtel-Dieu Clermont-Ferrand
France Hôpital Beaujon Clichy
France Hôpital Pasteur Colmar
France Centre Hospitalier de Compiègne Compiegne
France Hôpital Henri Mondor Creteil
France Centre Hospitalier Victor Jousselin Dreux
France Clinique Sainte Marguerite Hyeres
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 Hôpital Site de Lorient Lorient
France Hôpital de la Croix Rousse Lyon
France Hôpital de l'Archet 2 Nice
France Hôpital de la Source Orléans
France Centre de Radiothérapie et Oncologie Médicale Osny
France Hôpital des Diaconesses Paris
France Hôpital du Val de Grâce Paris
France Hôpital Georges Pompidou Paris
France Hôpital Pitié Salpêtrière Paris
France Hôpital Saint Antoine Paris
France Hôtel Dieu Paris
France Institue Curie Paris
France Centre Hospitalier Lyon Sud Pierre Benite
France Institut Jean Godinot Reims
France Centre Eugène Marquis Rennes
France Centre Hospitalier de Roanne Roanne
France CAC Becquerel Rouen
France Hôpital Charles Nicolle Rouen
France Institut de Cancérologie de la Loire Saint Etienne
France Clinique Armoricaine de Radiologie Saint-Brieuc
France Clinique Guillaume de Varye Saint-Doulchard
France Centre Hospitalier Gaston Ramon Sens
France Hôpital Civil Strasbourg
France Hôpital Hautepierre Strasbourg
France C.H.R. de Metz-Thionville Thionville
France Hôpital de Rangueil Toulouse
France Hôpital Joseph Ducuing Toulouse
France Institut Gustave Roussy Villejuif
Netherlands Academisch Medisch Centrum Amsterdam

Sponsors (1)

Lead Sponsor Collaborator
Ipsen

Countries where clinical trial is conducted

Belgium,  France,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) On day 7 (plus 1 day at the latest) after the first injection
Secondary Number of daily vomiting episodes or measurement of the daily drainage by NGT Daily for the duration of the study
Secondary Number of days with no vomiting episodes For the duration of the study
Secondary Number of daily nausea episodes Daily for the duration of the study
Secondary Intensity of abdominal pain Daily for the duration of the study
Secondary Well-being Daily for the duration of the study
Secondary Symptom relief duration Between the first day of clinical response and the end of follow-up
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