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EnterostomyPhase 2SOMILEONCT02713776

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

A Phase 2 study testing Pasireotide in people with Enterostomy, run by Hospices Civils de Lyon at 14 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Enterostomy
What is being tested?
Pasireotide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
57 participants
Where
14 sitesFrance
Study dates
13 Dec 2016to 8 Jan 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and Female patients ≥ 18 years old ;
  • Patients who underwent an intestinal surgery with enterostomy repair in the three weeks preceding the inclusion ;
  • 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.

Who cannot join

  • 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 ;
Show all 17Show fewer
  • 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 ;
  • Patients nonaffiliated to a social insurance regime.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • Chu Amiens-Picardie

    Amiens, 80054

  • Chu Estaing

    Clermont-Ferrand, 63003

  • Hopital Beaujon

    Clichy, 92110

  • Chu Albert Michallon

    La Tronche, 38700

  • Hôpital Claude HURIEZ - CHRU Lille

    Lille, 59 067

  • Centre Leon Berard

    Lyon, 69008

  • Chu Marseille - Hopital Nord

    Marseille, 13 915

  • Institut Regional Du Cancer Val D'Aurelle

    Montpellier, 34298

  • Chu Caremeau

    Nîmes, 30029

  • Hopital Saint Antoine

    Paris, 75012

  • Bordeaux Chu - Hopital Haut-Leveque

    Pessac, 33600

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Chu Rouen Ch. Nicolle

    Rouen, 76031

  • Toulouse - Chu Purpan

    Toulouse, 31059

Other trials in France

About this study

Official title: Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment : Phase II Multicentric Randomized Double Bland Placebo Controlled Study

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
Being tested
Pasireotide, Placebo
Keywords
High-Output Enterostomy, Pasireotide, Somatostatin Analogues

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PasireotideDrug

    Also called Pasireotide 0.9 mg (SIGNIFOR®) and Pasireotide 60mg Long Acting Release (LAR)

    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.

  • PlaceboDrug

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

Study groups in NCT02713776
Study groupRoleWhat they receive
PasireotideExperimentalPasireotide 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.
Receives: Drug: Pasireotide
PlaceboPlacebo comparatorPlacebo by subcutaneous injection twice a day during 3 days and 1 intramuscular injection of placebo on Day 4 morning.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Evaluated 72 hours after first injection of treatment

Secondary outcomes (5)

  1. Estimate the success rate of pasireotide and placebo

    Number of normal renal function patients in both arms with an enterostomy output than 800 millimeters (mL) /24h within a week after first injection of treatment allowing discontinuation of intravenous perfusion.

    Measured: 1 week after first injection of treatment

  2. Compare the decrease in the length of hospitalization with pasireotide versus placebo

    Duration of hospitalization in days in both arms

    Measured: 1 month after the end of treatment

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

    Rate of premature closure of stoma due to high-output (before 2 months after creation) in both arms

    Measured: 2 months after enterostomy creation

  4. Evaluate the economic impact of pasireotide in this indication

    Costs of taking care of patients from French Public Health Insurance perspective in both arms

    Measured: 2 months from the inclusion of the patient in the study

  5. Incidence of treatment - Emergent Adverse Events

    Nature, number and grade of adverse events observed throughout the study

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2016 (estimated)
  2. Study start13 Dec 2016
  3. Primary completion8 Jan 2021
  4. Study completion8 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02713776
Sponsor's protocol ID
2014_880
Acronym
SOMILEO
Status last verified
Dec 2025
First submitted
29 Feb 2016
Last updated
19 Dec 2025
Results posted
No

Publications

  • 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.

    PubMed 35427770

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pasireotide in people with Enterostomy, run by Hospices Civils de Lyon at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the efficacy of pasireotide versus placebo in reduction of high-output (time frame: Evaluated 72 hours after first injection of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02713776, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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