Patients with high-output ileostomy or jejunostomy and failure of treatment with loperamide +/- codein syrup MedDRA version: 18.1 Level: PT Classification code 10021321 Term: Ileostomy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 18.1 Level: PT Classification code 10023180 Term: Jejunostomy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: SIGNIFOR
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PASIREOTIDE DIASPARTATE
Other descriptive name: Signifor
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Hospices Civils de Lyon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and Female patients = 18 years old ; - Patients with high-output ileostomy or jejunostomy > 1000 ml/24h ; - Patients with failure of treatment with loperamide (up to 8 capsules/24h) +/- codein syrup (10 mg x 3/24h) during 5 days ; - Patients who gave its written informed consent to participate to the study ; - Patients affiliated to a social insurance regime. 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 52 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: - Male and Female patients 8%) ; - Patients who are hypothyroid and not on adequate replacement therapy ; - Patients who have congestive heart failure (NYHA (New York Heart Association) Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, advanced heart block or a history of clinically significant bradycardia or acute myocardial infarction within the 6 months preceding randomization ; - Patients with history of syncope or family history of idiopathic sudden death ; - Patients with screening or baseline (predose) : QTcF > 450 msec (male), QTcF > 460 msec (female) (QT interval corrected for heart rate using Fridericia's correction) ; - Patients with not corrected hypokalaemia and/or hypomagnesaemia ; - Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis, or patients with ALT/AST (alanine transaminase/aspartate transaminase) > 2 x ULN (Upper Limit of Normal), serum bilirubin > 2 x ULN ; - Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control ; - Patients with active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix) ; - Patients with abnormal coagulation (PT and/or APTT elevated by 30% above normal limits) or patients receiving anticoagulants that affect PT (prothrombin time) or APTT (activated partial thromboplastin time) ; - Patients with known hypersensitivity to somatostatin analogues or any other component of the pasireotide LAR ; - Patients under guardianship ; - Patients nonaffiliated to a social insurance regime.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare the efficacy of pasireotide versus placebo in reduction of high-output (>1000 ml/24h) enterostomy in patients refractory to usual medical treatment;Secondary Objective: - Estimate the success rate of pasireotide and placebo. - Compare the decrease in the length of hospitalization with pasireotide versus placebo. - Compare the incidence of prematured closure of stoma due to high-output with pasireotide versus placebo. - Evaluate the economic impact of pasireotide in this indication. - Evaluate the safety of pasireotide in this indication. ;Primary end point(s): The decrease of enterostomy output (ml/24H) evaluated 72 hours after first injection of treatment, in both arms.;Timepoint(s) of evaluation of this end point: 72 hours after first injection of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of patients in both arms with an enterostomy output less than 800ml/24h AND a normal renal function (Glomerular Filtration Rate> 90 ml/min according to Cockroft formula) within a week after first injection of treatment, allowing discontinuation of intravenous perfusion. - Duration of hospitalization (days), in both arms. - Rate of prematured closure of stoma due to high output (before 2 months after creation), in both arms. - Costs of taking care of patients from French Public Health Insurance perspective, in both arms (see section 11). - Nature, number and grade of adverse events observed throughout the study. ;Timepoint(s) of evaluation of this end point: - Number of patients in both arms with an enterostomy output less than 800ml/24h AND a normal renal function within a week after first injection of treatment, allowing discontinuation of intravenous perfusion. - Rate of prematured closure of stoma due to high output (before 2 months after creation), in both arms. | — |
Countries
France
Contacts
Public ContactClinical trial Information
Hospices Civils de Lyon
Outcome results
None listed