Inoperable malignant bowel obstruction MedDRA version: 17.0 Level: PT Classification code 10061974 Term: Gastrointestinal obstruction System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Ipstyl 120 mg
Product Name: IPSTYL
Product Code: 52030
Pharmaceutical Form: Injection
Sponsors
IPSEN S.p.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the impact on Quality of Life (Edmonton Symptom Assessment System, ESAS total score) of LAN ATG 120 mg in combination with standard care, in comparison to the standard care alone. ; Secondary Objective: 1) To evaluate the impact of LAN ATG 120 mg on each ESAS item and total score; 2) To assess General activity (Karnofsky performance status) and Abdominal Pain (Visual analogue scale); 3) To assess the efficacy of LAN ATG 120 mg for the relief of vomiting in patients without nasogastric tube (NGT); 4) To assess the efficacy of LAN ATG 120 mg on NGT secretion volumes or to remove NGT without recurrence of vomiting in patients with a nasogastric tube; 5) Passage of stools (Yes/No); 6) Descriptive analysis of optional ESAS item 10; 7) To assess the efficacy in reducing concomitant medications/ analgesics intake. ; Primary end point(s): Comparison between the mean AUC of ESAS Total Scores collected for the first 7 days in patients with Standard care + 1 injection of LAN ATG 120 mg (Group A) and the corresponding mean AUC in patients with standard care alone (Group B). ESAS total score is the sum of nine common symptoms affecting patients with cancer in their terminal phase of life. It consists of nine 0–10 numerical scales: pain, activity, nausea, depression, anxiety, drowsiness, appetite, sense of well-being and shortness of breath. There is an optional tenth scale based on a symptom, which can be added by the patient. Analysis of the primary endpoint will be performed on the first defined 9 items total score. ESAS questionnaire will be assessed by the patient or filled in by the nurse/caregiver in case of patient’s physical inability. ;Timepoint(s) of evaluation of this end point: For both treatment groups ("A" standard therapy + 1 injection of 120 mg AG LAN | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Depending on the endpoint detection times are detailed in the description of the endpoint in the same section. 5.2; Secondary end point(s): - Secondary Efficacy Endpoints and Evaluations: 1) Comparison of single ESAS items symptom score and total score at Day 1,2,3,4,5,6 and 7, Day 14, Day 28, between Group A and Group B; 2) Changes in performing General activity (Karnofsky performance status) at Day 7, Day 14 and Day 28 compared to baseline and comparison between Group A and Group B; 3) Changes in daily intensity of Abdominal Pain (Visual analogue scale) and comparison between Group A and Group B; 4) Comparison of number of patients experiencing = 2 vomiting episodes/day during at least 3 consecutive days at any time point between the D1 and D7,14,28, between Group A and Group B, in patients without nasogastric tube (NGT); 5) Comparison of number of patients in whom the NGT has been removed during at least 3 consecutive days at any time point, between the D1 and D7, 14, 28, without vomiting recurrence, between Group A and Group B; 6) In patients with a NGT, changes in daily NGT secretion volume and comparison between Group A and Group B; 7) Comparison of number of daily vomiting episodes and number of days without vomiting, between Group A and Group B; 8) Passage of stools (Yes/No) daily assessment and comparison between Group A and Group B; 9) Descriptive analysis of optional ESAS item 10; 10) Standard care and concomitant medications will be recorded and analysed. In particular changes in analgesic intake. | — |
Countries
Italy
Contacts
Public ContactDirezione Medica
IPSEN S.p.A
Outcome results
None listed