EUCTR2005-002349-38-NLActive, not recruitingNot Applicable
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
Beaufour Ipsen Pharma-Ipsen Biotech Department0 sites80 target enrollmentStarted: December 22, 2006Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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,
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