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
- intestinal obstructionperitoneal carcinomatosis1001800810017991
- Registration Number
- NL-OMON30314
- Lead Sponsor
- Ipsen Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 6
- Patient having given written (personally signed and dated) 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 origin.
- Patient having a peritoneal carcinomatosis confirmed by a CT Scan within the previous 3 months
- Patient having an obstruction with at least two vomiting episodes per day or the presence of a nasogastric suction tube
- Patient for whom surgery is inappropriate, either documented in the medical records or confirmed by a surgical advice within the previous 72 hours
- Patients being treated by intra-venous corticoids since at least 5 days and intravenous proton pump inhibitors
- Patients having an estimated survival of more than one month
- Patients accepting to comply fully with the protocol.
- Patient having an operable obstruction
- Patient having a colic obstruction (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 blockers
- Patient having a bowel obstruction which could be explained by a non malignant cause (e.g. 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 contraindication to intra-muscular injections
- Patient having a known hypersensitivity to any of the test materials or related compounds
- Patient having previously entered this study
- Patient having been included in another clinical study within the previous 30 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary efficacy criteria:<br /><br>Pecentage of responder patients at D7.<br /><br>A responder patient will be defined either as a patient experiencing one or<br /><br>less vomiting episode per day during at least three consecutive days or as a<br /><br>patient in whom NGT has been removed during at least three consecutive days<br /><br>without vomiting recurrence.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary criteria:<br /><br>Efficacy criteria<br /><br>- Number of daily vomiting episodes recorded in the diary cards or measurement<br /><br>of the daily drainage by NGT<br /><br>- Number of days with no vomiting episodes<br /><br>- Number of daily nausea episodes recorded on diary cards<br /><br>- intensity of abdominal pain assessed on a visual analogue scale<br /><br>- Well-being assessed on a visual analogue scale<br /><br>- Time between first injection (inclusion) and clinical response<br /><br>- Symptom relief duration<br /><br>- Symtomatic concomitant treatment consumption<br /><br>- Hospitalisation duration<br /><br>Safety criteria<br /><br>- Clinical and biological adverse events</p><br>