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

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ClinicalTrials.gov Identifier: NCT02054637
Recruitment Status : Unknown
Verified January 2014 by Kim Moubax, Universitair Ziekenhuis Brussel.
Recruitment status was:  Not yet recruiting
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Kim Moubax, Universitair Ziekenhuis Brussel

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Acid Reflux Esophagitis Non-acid Reflux Esophagitis Drug: Lanreotide Phase 2

Detailed Description:

Patients presenting with persistent esophagitis on endoscopy while on proton pump inhibitors (PPI) treatment will receive a maximal therapy consisting of 2 x 40 mg of PPI before the meals (morning and evening) and a H2 blocker before bedtime (standard practice). They will be reevaluated endoscopically and clinically 2 months later (standard practice). If reflux persists, objectivized by impedancemetry (standard practice), they will be asked to participate in this study.

Lanreotide autogel 120 mg deep subcutaneously every 4 weeks will be added to the treatment. A total of 3 injections per patient have been foreseen in this proof of concept study.

Patients will be reevaluated clinically after 2, 4 and 8 weeks. At the end of the study a new upper gastrointestinal endoscopy and impedancemetry will be performed.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy
Study Start Date : April 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Lanreotide
Lanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections)
Drug: Lanreotide
Other Name: Somatuline




Primary Outcome Measures :
  1. Los Angeles criteria for reflux esophagitis [ Time Frame: 4 weeks after the last injection with lanreotide ]
    Endoscopy at the start of the study will be compared with endoscopy at the end of the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054637


Contacts
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Contact: Kim Moubax, Assistent 003224749346 ext 0032476486103 kimmoubax970@hotmail.com/kim.moubax@uzbrussel.be
Contact: Daniël Urbain, Professor daniel.urbain@uzbrussel.be

Locations
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Belgium
University Hospital of Brussels Not yet recruiting
Jette, Belgium, 1090
Contact: Kim Moubax, Assistent    003224749346 ext 0032476486103    kimmoubax970@hotmail.com/kim.moubax@uzbrussel.be   
Contact: Daniël Urbain, Professor       daniel.urbain@uzbrussel.be   
Principal Investigator: kim moubax, assistent         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Study Chair: Kim Moubax, Assistent University hospital of Brussels, Laarbeeklaan, Jette

Publications:

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Responsible Party: Kim Moubax, Dr. Kim Moubax, gastro-enterology, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02054637     History of Changes
Other Study ID Numbers: PHV106-B.05
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: January 2014
Keywords provided by Kim Moubax, Universitair Ziekenhuis Brussel:
Bile reflux
Reflux esophagitis
Lanreotide autogel
Somatuline
Endoscopy
Impedancemetry
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophagitis
Bile Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Biliary Tract Diseases
Duodenogastric Reflux
Lanreotide
Angiopeptin
Somatostatin
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs