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Trial · Interventional

Status unknownPhase 2Registry data

Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy

NCTNCT02054637 (opens ClinicalTrials.gov in a new tab)Other idPHV106-B.05
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 2
Enrollment
10 participants (estimated)
Sponsor
Universitair Ziekenhuis Brussel · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Belgium

Start
Apr 2014
Primary completion
Dec 2015 (estimated)
Completion
Apr 2016 (estimated)
First posted
4 Feb 2014 (estimated)
Last update posted
4 Feb 2014 (estimated)
Conditions
Acid Reflux Esophagitis · Non-acid Reflux Esophagitis

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2014201520162017
  1. Ph 2

    Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy

    NCT02054637

    Apr 2014 to est. Apr 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Somatostatine induces a dose-dependent reduction of postprandial plasma cholecystokinin (CCK) secretion with a concomitant inhibition of postprandial gallbladder contraction, abolishing almost completely bile salts output from the gallbladder. Somatostatine is also known to decrease acid production with significant increase of intragastric pH. In this way, somatostatine could influence acid as well as non-acid reflux by decreasing gallbladder emptying and decreasing acid secretion. Purpose of the study is to evaluate the efficacy of lanreotide autogel 120 mg on symptoms and endoscopic lesions in patients with an endoscopic gastrointestinal reflux esophagitis that cannot be controlled with classic therapy.

Interventions

  • LanreotideDrug

Arms1

  • Experimental

    Lanreotide

    Lanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Los Angeles criteria for reflux esophagitis

    Time frame · 4 weeks after the last injection with lanreotide

    Registry description

    Endoscopy at the start of the study will be compared with endoscopy at the end of the study.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 1999

6 results

Dose-dependent gastrointestinal effects of the somatostatin analog lanreotide in healthy volunteers.

Drewe et al. 1999Clinical pharmacology and therapeuticscited by 6

PMID 10223779DOI 10.1016/s0009-9236(99)70136-0PUB-10223779

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 1997

7 results

Effects of lanreotide, a somatostatin analogue, on postprandial gastric functions and biliopancreatic secretions in humans.

Lamrani et al. 1997British journal of clinical pharmacologycited by 12

PMID 9056054DOI 10.1111/j.1365-2125.1997.tb00034.xPUB-09056054

Full text at the publisher7 results
Publisher pageSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Persistent endoscopic reflux in spite of maximal medical therapy with PPI 2 x 40 mg (before breakfast and dinner) and 300 mg of H2 blocker ranitidine (at bedtime). The Los Angeles classification (LA) will be used to evaluate endoscopic reflux. Any distal esophageal ulcer with negative biopsy is also diagnostic for reflux. Persistent reflux is defined as: No reflux complaints but continuing endoscopic lesions and positive impedancemetry. Reflux complaints with continuing endoscopic lesions and positive impedancemetry. Reflux complaints without endoscopic lesions but positive impedancemetry. Exclusion Criteria: * Pregnancy or inadequate anticonception, breast feeding. * Negative impedancemetry. * Diabetes. * Placement of a gastric ring for weight loss.

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