NCT02490449

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

July 3, 2015

Status Verified

July 1, 2015

Enrollment Period

1 year

First QC Date

December 13, 2014

Last Update Submit

July 2, 2015

Conditions

Nonerosive Reflux Disease

Outcome Measures

Primary Outcomes (1)

  • Percentage (%) of patients free of reflux symptoms

    4 weeks

Study Arms (2)

Exprerimental group

EXPERIMENTAL

medication after diet

Drug: Dexlansoprazole MR

control group

ACTIVE COMPARATOR

medication before diet

Drug: Dexlansoprazole MR

Interventions

Dexlansoprazole MRDRUG

Administration of drug after or before diet

Exprerimental groupcontrol group

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NERD confirmed by gastroscopy

You may not qualify if:

  • PPI medication within 2 weeks before enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine

Bucheon-si, Gyeonggi-do, 420-767, South Korea

Location

Study Officials

  • Su Jin Hong

    Soonchunhyang University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 13, 2014

First Posted

July 3, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Last Updated

July 3, 2015

Record last verified: 2015-07

Locations

KR(1)