Reduction by pasireotide of the effluent volume in high-output enterostomy in patients refractory to usual medical treatment.

Phase 1

• Conditions: Patients with high-output ileostomy or jejunostomy and failure of treatment with loperamide +/- codein syrup; MedDRA version: 18.1Level: PTClassification code 10021321Term: IleostomySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: PTClassification code 10023180Term: JejunostomySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2014-004707-67-FR
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-29
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 78

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

-Male and Female patients < 18 years old ;
-Patients who did not give its written informed consent to participate to the study ;
-Patients who received somatostatin analogues during the month before inclusion ;
-Patients with symptomatic cholelithiasis or acute or chronic pancreatitis ;
-Patients with uncontrolled diabetes (with HbA1c (glycated hemoglobin) > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified