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.
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2015
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.
- Drug: Lanreotide
Arms, Groups and Cohorts
- Experimental: Lanreotide
- Lanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections)
Clinical Trial Outcome Measures
- 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.
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Provider of Information About this Clinical Study
- Principal Investigator: Kim Moubax, Dr. Kim Moubax, gastro-enterology – Universitair Ziekenhuis Brussel
- Overall Official(s)
- Kim Moubax, Assistent, Study Chair, University hospital of Brussels, Laarbeeklaan, Jette
- Overall Contact(s)
- Kim Moubax, Assistent, 003224749346, firstname.lastname@example.orgemail@example.com
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