Resolving Bile Reflux by Lanreotide in Patients With Roux... | NCT02054637

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

NCT02054637

Sponsor

Universitair Ziekenhuis Brussel

Status

Unknown status

Last Update Posted

Feb 4, 2014Estimated

Enrollment

10Estimated

Phase

Phase 2

Conditions

Acid Reflux Esophagitis
Non-acid Reflux Esophagitis

Interventions

Lanreotide

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Apr 2016Estimated

First Submitted Date

Jan 29, 2014

First Submission Date that Met QC Criteria

Jan 31, 2014

First Posted Date

Feb 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2014

Last Update Posted Date

Feb 4, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lanreotide	Experimental	Lanreotide autogel 120mg injection every 4 weeks (every patient will receive 3 injections)	Drug: Lanreotide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lanreotide	Drug		Lanreotide	Somatuline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Los Angeles criteria for reflux esophagitis	Endoscopy at the start of the study will be compared with endoscopy at the end of the study.	4 weeks after the last injection with lanreotide

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kim Moubax, Assistent	Contact	003224749346	0032476486103	kimmoubax970@hotmail.com/kim.moubax@uzbrussel.be
Daniël Urbain, Professor	Contact			daniel.urbain@uzbrussel.be

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Brussels		Jette		1090	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16240061	Background	Ishikawa M, Kitayama J, Kaizaki S, Nakayama H, Ishigami H, Fujii S, Suzuki H, Inoue T, Sako A, Asakage M, Yamashita H, Hatono K, Nagawa H. Prospective randomized trial comparing Billroth I and Roux-en-Y procedures after distal gastrectomy for gastric carcinoma. World J Surg. 2005 Nov;29(11):1415-20; discussion 1421. doi: 10.1007/s00268-005-7830-0.
12239969

ID	Term
D001655	Bile Reflux
D004942	Esophagitis, Peptic

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D004383	Duodenogastric Reflux
D013272	Stomach Diseases