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

Lead Sponsor

Universitair Ziekenhuis Brussel

Source

Universitair Ziekenhuis Brussel

Oversight Info

Has Dmc

Yes

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.

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.

Overall Status

Unknown status

Start Date

2014-04-01

Completion Date

2016-04-01

Primary Completion Date

2015-12-01

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure	Time Frame
Los Angeles criteria for reflux esophagitis	4 weeks after the last injection with lanreotide

Enrollment

Conditions

Acid Reflux Esophagitis

, Non-acid Reflux Esophagitis

Intervention

Intervention Type

Drug

Intervention Name

Lanreotide

Arm Group Label

Lanreotide

Other Name

Somatuline

Eligibility

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.

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

Accepts Healthy Volunteers

Overall Official

Last Name	Role	Affiliation
Kim Moubax, Assistent	Study Chair	University hospital of Brussels, Laarbeeklaan, Jette

Overall Contact

Last Name

Kim Moubax, Assistent

Phone

003224749346

Phone Ext

0032476486103

Email

[email protected]/[email protected]

Location

Facility	Status	Contact	Investigator
University Hospital of Brussels Jette 1090 Belgium	Not yet recruiting	Last Name: Kim Moubax, Assistent Phone: 003224749346 Phone Ext: 0032476486103 Email: [email protected]com/[email protected]	Last Name: kim moubax, assistent Role: Principal Investigator

Location Countries

Country

Belgium

Verification Date

2014-01-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Universitair Ziekenhuis Brussel

Investigator Full Name

Kim Moubax

Investigator Title

Dr. Kim Moubax, gastro-enterology

Keywords

Bile reflux

, Reflux esophagitis

, Lanreotide autogel

, Somatuline

, Endoscopy

, Impedancemetry

Has Expanded Access

Condition Browse

Gastroesophageal Reflux

, Esophagitis, Peptic

, Esophagitis

, Bile Reflux

Number Of Arms

Intervention Browse

Mesh Term

Lanreotide

Angiopeptin

Somatostatin

Arm Group

Arm Group Label

Lanreotide

Arm Group Type

Experimental

Description

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

Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Daniël Urbain, Professor

Email

[email protected]

Not yet recruiting

ClinicalTrials.gov processed this data on December 10, 2019

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.

Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.

Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.

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