A PHASE II, MULTICENTRE, RANDOMIZED CONTROLLED STUDY EVALUATING THE QUALITY OF LIFE IN PATIENTS WITH INOPERABLE MALIGNANT BOWEL OBSTRUCTION TREATED WITH LANREOTIDE AUTOGEL 120 MG IN COMBINATION WITH STANDARD CARE VS. STANDARD CARE ALONE
- Conditions
- Inoperable malignant bowel obstructionMedDRA version: 17.0 Level: PT Classification code 10061974 Term: Gastrointestinal obstruction System Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003176-12-IT
- Lead Sponsor
- IPSEN S.p.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 43
1)Subjects must demonstrate willingness to participate in the study and to be compliant with any protocol procedure.
2)Provision of written informed consent prior to any study related procedure.
3)Male or female aged = 18 years at the time of enrolment.
4)Diagnosis of an inoperable malignant bowel obstruction, confirmed by appropriate imaging report.
5)In case of peritoneal carcinomatosis, diagnostic confirmation by CT or MRI scan;
6)Confirmed as inoperable after medical advice;
7)Patient with a nasogastric tube or presenting with 3 or more episodes of vomiting every day in the last consecutive 48 hours;
8)Patient life expectancy must be more than 14 days.
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 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1)Operable obstruction or any subobstruction;
2)Bowel obstruction due to a non-malignant cause; (hypokaliaemia, drug side-effects, renal insufficiency, etc)
3)Signs of bowel perforation;
4)Prior treatment with somatostatin or any analogue within the previous 60 days;
5)A known hypersensitivity to any of the study treatments or related compounds.
6)Is likely to require treatment during the study with somatostatin or any analogue other than the study treatment.
7)Is at risk of pregnancy or lactation, or is likely to father a child during the study. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral or double barrier contraception. Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study.
8)Has any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
9)Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method