Nonerosive Reflux DiseaseNCT02490449
Dexlansoprazole MR in Nonerosive Reflux Disease
A study testing Dexlansoprazole MR in people with Nonerosive Reflux Disease, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
This study aim is to compare the efficacy of Dexlansoprazole MR intake before and after breakfast in patients with nonerosive reflux disease. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonerosive Reflux Disease
- What is being tested?
- Dexlansoprazole MR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- NERD confirmed by gastroscopy
Who cannot join
- PPI medication within 2 weeks before enrollment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Digestive Disease Center, Department of Internal Medicine, Soonchunhyang University College of Medicine
Bucheon-si, Gyeonggi-do, 420-767
About this study
This study aim is to compare the efficacy of Dexlansoprazole MR intake before and after breakfast in patients with nonerosive reflux disease.
- Conditions
- Nonerosive Reflux Disease
- Being tested
- Dexlansoprazole MR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexlansoprazole MRDrug
Administration of drug after or before diet
| Study group | Role | What they receive |
|---|---|---|
| Exprerimental group | Experimental | medication after diet Receives: Drug: Dexlansoprazole MR |
| control group | Active comparator | medication before diet Receives: Drug: Dexlansoprazole MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage (%) of patients free of reflux symptoms
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonerosive Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su Jin Hong, Soonchunhyang University Hospital
- Investigators
- Su Jin Hong, Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490449
- Sponsor's protocol ID
- SCHBC 2014-05-021-002
- Status last verified
- Jul 2015
- First submitted
- 13 Dec 2014
- Last updated
- 3 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexlansoprazole MR in Nonerosive Reflux Disease
- ClinicalTrials.gov ID
- NCT02490449
- Acronym / sponsor ID
- SCHBC 2014-05-021-002
- Conditions
- Nonerosive Reflux Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aim is to compare the efficacy of Dexlansoprazole MR intake before and after breakfast in patients with nonerosive reflux disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exprerimental group | Experimental | Drug: Dexlansoprazole MRmedication after diet |
| control group | Active comparator | Drug: Dexlansoprazole MRmedication before diet |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- NERD confirmed by gastroscopy
Key exclusion criteria (1 listed)
- PPI medication within 2 weeks before enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexlansoprazole MRAdministration of drug after or before diet | Drug | Exprerimental group, control group |
Primary outcome
Percentage (%) of patients free of reflux symptoms
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
Related trials for Nonerosive Reflux Disease
Recruiting
New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease (The RELIEF Trial)
GERD (Gastroesophageal Reflux Disease), NERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Su Jin Hong principal investigator
Soonchunhyang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexlansoprazole MR in people with Nonerosive Reflux Disease, run by Soonchunhyang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage (%) of patients free of reflux symptoms (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2015.