Dexlansoprazole MR in Nonerosive Reflux Disease | NCT02490449

Studies
Dexlansoprazole MR in Nonerosive Reflux Disease

NCT02490449

Sponsor

Soonchunhyang University Hospital

Status

Unknown status

Last Update Posted

Jul 3, 2015Estimated

Enrollment

356Estimated

Phase

Not Applicable

Conditions

Nonerosive Reflux Disease

Interventions

Dexlansoprazole MR

Countries

South Korea

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

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Dec 13, 2014

First Submission Date that Met QC Criteria

Jul 2, 2015

First Posted Date

Jul 3, 2015Estimated

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

Jul 2, 2015

Last Update Posted Date

Jul 3, 2015Estimated

Description Module

Brief Summary

This study aim is to compare the efficacy of Dexlansoprazole MR intake before and after breakfast in patients with nonerosive reflux disease.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

356Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exprerimental group	Experimental	medication after diet	Drug: Dexlansoprazole MR
control group	Active Comparator	medication before diet	Drug: Dexlansoprazole MR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexlansoprazole MR	Drug	Administration of drug after or before diet	Exprerimental group control group

Measure	Description	Time Frame
Percentage (%) of patients free of reflux symptoms		4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

NERD confirmed by gastroscopy

Exclusion Criteria:

PPI medication within 2 weeks before enrollment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Su Jin Hong	Soonchunhyang University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine		Bucheon-si	Gyeonggi-do	420-767	South Korea