Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment

NCT02713776 | Completed Phase 2

• 1 other identifier: 2014_880
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 14

Brief Summary

During rectal or complex digestive surgery with multiple digestive resections and anastomosis, the creation of enterostomy is a common procedure. In France, it is estimated that 20000 patients have an ileostomy and 16000 new digestive stomas are formed each year with approximately 30% of enterostomy. Enterostomy might sometimes give high-output not controlled with usual medical treatment (e.g loperamide ± codeine) and exposes the patients to important hydro-electrolytic loss leading to a risk for dehydration, electrolyte abnormalities and acute renal failure. This risk implies parenteral correction which may extend hospital stay and delay home return. Somatostatin analogues (octreotide, lanreotide and pasireotide) could reduce digestive secretions and decrease digestive peristalsis. Nevertheless, somatostatin analogues are not routinely used for the treatment of patients with high-output enterostomy and their efficacy in the indication (off-label) was only tested in small case series. Pasireotide (SOM230, SIGNIFOR®) is currently indicated for the treatment of patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed. As the efficacity of pasireotide in patients with high-output enterostomy refractory to usual medical treatment associated with an oral fluid restriction has never been demonstrated before, there is a need to perform a pilot, double-blind, randomized, placebo-controlled trial evaluating its impact on reduction of the effluent volume.

Conditions

Enterostomy

Keywords

High-Output Enterostomy; Pasireotide; Somatostatin Analogues

Outcome Measures

Primary Outcomes (1)

• Compare the efficacy of pasireotide versus placebo in reduction of high-output

  Decrease of enterostomy output (ml/24H)within the 72 hours after first injection of treatment

  Evaluated 72 hours after first injection of treatment

Secondary Outcomes (5)

• Estimate the success rate of pasireotide and placebo

  1 week after first injection of treatment

• Compare the decrease in the length of hospitalization with pasireotide versus placebo

  1 month after the end of treatment

• Compare the incidence of premature closure of stoma due to high-output with pasireotide versus placebo

  2 months after enterostomy creation

• Evaluate the economic impact of pasireotide in this indication

  2 months from the inclusion of the patient in the study

• Incidence of treatment - Emergent Adverse Events

  during treatment (4 days), one week, two weeks, three weeks and one month after treatment

Study Arms (2)

Pasireotide

EXPERIMENTAL

Pasireotide 0.9 mg by subcutaneous injection twice a day during 3 days and 1 intramuscular injection of pasireotide Long Acting Release (LAR) 60mg on Day 4 morning.

Drug: Pasireotide

Placebo

PLACEBO COMPARATOR

Placebo by subcutaneous injection twice a day during 3 days and 1 intramuscular injection of placebo on Day 4 morning.

Drug: Placebo

Interventions

Pasireotide DRUG

Pasireotide 0.9 mg by subcutaneous injection twice a day during 3 days and 1 intramuscular injection of pasireotide Long Acting Release (LAR) 60mg on Day 4 morning.

Also known as: Pasireotide 0.9 mg (SIGNIFOR®) and Pasireotide 60mg Long Acting Release (LAR)

Pasireotide

Placebo DRUG

Placebo by subcutaneous injection twice a day during 3 days and 1 intramuscular injection of placebo on Day 4 morning.

Also known as: Placebo of pasireotide 0.9 mg by subcutaneous injection twice a day during 3 days and 1 intramuscular injection of pasireotide LAR (Long Acting Release) 60mg on Day 4

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female patients ≥ 18 years old ;
• Patients with high-output ileostomy or jejunostomy \> 1000 ml/24h ;
• Patients with failure of treatment combining oral fluid restriction and loperamide (up to 8 capsules/24h) +/- codeine 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.

You may not qualify if:

• Male and Female patients \< 18 years old ;
• Patients who did not give its written informed consent to participate to the study ;
• 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) : QT interval corrected for heart rate using Fridericia's correction (QTcF) 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 alanine transaminase/aspartate transaminase (ALT/AST) \> 2 x Upper Limit of Normal (ULN), serum bilirubin \> 2 x ULN ;
• Patients with Child-Pugh C cirrhosis ;
• Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control ;
• Patients with abnormal coagulation (PT and/or APTT elevated by 30% above normal limits) or patients receiving anticoagulants that affect PT (prothrombin time) or activated partial thromboplastin time (APTT) ;
• Patients with known hypersensitivity to somatostatin analogues or any other component of the pasireotide LAR ;
• Patients under guardianship ;

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (14)

Chu Amiens-Picardie

Amiens, 80054, France

Location

Chu Estaing

Clermont-Ferrand, 63003, France

Location

Hopital Beaujon

Clichy, 92110, France

Location

Chu Albert Michallon

La Tronche, 38700, France

Location

Hôpital Claude HURIEZ - CHRU Lille

Lille, 59 067, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Chu Marseille - Hopital Nord

Marseille, 13 915, France

Location

Institut Regional Du Cancer Val D'Aurelle

Montpellier, 34298, France

Location

Chu Caremeau

Nîmes, 30029, France

Location

Hopital Saint Antoine

Paris, 75012, France

Location

Bordeaux Chu - Hopital Haut-Leveque

Pessac, 33600, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Chu Rouen Ch. Nicolle

Rouen, 76031, France

Location

Toulouse - Chu Purpan

Toulouse, 31059, France

Location

Related Publications (1)

• Beffara B, Hadj-Bouziane F, Hamed SB, Boehler CN, Chelazzi L, Santandrea E, Macaluso E. Dynamic causal interactions between occipital and parietal cortex explain how endogenous spatial attention and stimulus-driven salience jointly shape the distribution of processing priorities in 2D visual space. Neuroimage. 2022 Jul 15;255:119206. doi: 10.1016/j.neuroimage.2022.119206. Epub 2022 Apr 12.

  PMID: 35427770 RESULT

MeSH Terms

Interventions

pasireotide

Study Officials

• Eddy COTTE, Professor

  Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 21, 2016
• Study Start: December 13, 2016
• Primary Completion: January 8, 2021
• Study Completion: January 8, 2021
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (14)