Phase III multicentre, Randomised, Double Blind, Comparative study to assess the efficacy and safety of lanreotide 30mg versus placebo as a palliative treatment of clinical symptoms associated with intestinal obstruction due to peritoneal carcinomatosis in inoperable patients

• Conditions: Patient having a high digestive obstruction of malignant origin i.e. located on the upper part of the gastro-intestinal tract (stomach, duodenum, small bowel) for whom surgery is inappropriate.

• Registration Number: EUCTR2005-002349-38-NL
• Lead Sponsor: Beaufour Ipsen Pharma-Ipsen Biotech Department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

•Patient having given a written informed consent before completing any study-related procedure,
•Patient being over 18 years of age,
•Patient having a high digestive obstruction i.e. located on the upper part of the gastro-intestinal tract (stomach, duodenum, small bowel) ,
•Patient having a digestive obstruction of malignant origin1,
•Patient having peritoneal carcinomatosis confirmed by a CT Scan within the previous 3 months1,
•Patient having an obstruction with at least two vomiting episodes per day or the presence of a nasogastric suction tube1,
•Patient for whom surgery is inappropriate, either documented in the medical records or confirmed by a surgical advice within the previous 72 hours1,
•Patient being treated by intra-venous corticoids since at least 5 days and intra-venous proton pump inhibitors,
•Patient having an estimated survival of more than one month,
•Patient accepting to comply fully with the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient having an operable obstruction1,
•Patient having a colic obstruction1 (must be documented by an abdominal X-Ray within the previous 3 days),
•Patient having received any specific anticancer therapy within the previous 15 days,
•Patient receiving any antiH2 receptor blockers1,
•Patient having a bowel obstruction which could be explained by a non malignant cause (hypokaliaemia, drug side-effects, renal insufficiency,..),
•Patient having signs of bowel perforation,
•Patient having received somatostatin or any analogue as treatment of the bowel obstruction,
•Patient having a contra-indication to intra-muscular injections,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified