Resolving Bile Reflux by Lanreotide in Patients With Roux-en-Y Gastrojejunostomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Lanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections)
Other Name: Somatuline
- 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.
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
|Contact: Kim Moubax, Assistent||003224749346 ext firstname.lastname@example.orgemail@example.com|
|Contact: Daniël Urbain, Professorfirstname.lastname@example.org|
|University Hospital of Brussels|
|Jette, Belgium, 1090|
|Contact: Kim Moubax, Assistent 003224749346 ext 0032476486103 email@example.comfirstname.lastname@example.org|
|Contact: Daniël Urbain, Professor email@example.com|
|Principal Investigator: kim moubax, assistent|
|Study Chair:||Kim Moubax, Assistent||University hospital of Brussels, Laarbeeklaan, Jette|