Back to resultsDexlansoprazole MR in Nonerosive Reflux Disease
Primary Purpose
Nonerosive Reflux Disease
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexlansoprazole MR
Sponsored by
About this trial
This is an interventional treatment trial for Nonerosive Reflux Disease
Eligibility Criteria
Inclusion Criteria:
- NERD confirmed by gastroscopy
Exclusion Criteria:
- PPI medication within 2 weeks before enrollment
Sites / Locations
- Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exprerimental group
control group
Arm Description
medication after diet
medication before diet
Outcomes
Primary Outcome Measures
Percentage (%) of patients free of reflux symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT02490449
First Posted
December 13, 2014
Last Updated
July 2, 2015
Sponsor
Soonchunhyang University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02490449
Brief Title
Dexlansoprazole MR in Nonerosive Reflux Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soonchunhyang University Hospital
4. Oversight
5. Study Description
Brief Summary
This study aim is to compare the efficacy of Dexlansoprazole MR intake before and after breakfast in patients with nonerosive reflux disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonerosive Reflux Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
356 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exprerimental group
Arm Type
Experimental
Arm Description
medication after diet
Arm Title
control group
Arm Type
Active Comparator
Arm Description
medication before diet
Intervention Type
Drug
Intervention Name(s)
Dexlansoprazole MR
Intervention Description
Administration of drug after or before diet
Primary Outcome Measure Information:
Title
Percentage (%) of patients free of reflux symptoms
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
NERD confirmed by gastroscopy
Exclusion Criteria:
PPI medication within 2 weeks before enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su Jin Hong
Organizational Affiliation
Soonchunhyang University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine
City
Bucheon
State/Province
Gyeonggi-do
ZIP/Postal Code
420-767
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Dexlansoprazole MR in Nonerosive Reflux Disease
We'll reach out to this number within 24 hrs