A Phase 2 interventional study of Lanreotide in Acid Reflux Esophagitis and Non-acid Reflux Esophagitis, sponsored by Universitair Ziekenhuis Brussel. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-04.
Sponsored by Universitair Ziekenhuis Brussel · Phase 2, Interventional, and Treatment
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.
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's planned enrollment of 10 is below the median of 72 across 711 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.
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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:
Lanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections)
Drug: Lanreotide
Also known as: Somatuline
Los Angeles criteria for reflux esophagitis
Endoscopy at the start of the study will be compared with endoscopy at the end of the study.
Time frame: 4 weeks after the last injection with lanreotide
This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Universitair Ziekenhuis Brussel