Non-erosive Gatroesophageal Reflux DiseaseNCT03436914
Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease
A study testing PPI in people with Non-erosive Gatroesophageal Reflux Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
For ERD(erosive reflux disease), which pathogenesis is mainly the acid reflux mechanism, primary treatment is therefore PPI. However, NERD(non-erosive reflux disease) is much more complex than ERD and there are more factors causing the typical symptoms. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Non-erosive Gatroesophageal Reflux Disease
- What is being tested?
- PPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2018to 18 Oct 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 19 years old
- Patient with typical GERD symptom (heartburn or acid reflux more than once a week)
Who cannot join
- Patient who received EGD since the past 6 months, and diagnosed as GERD endoscopically
- Patient with active gastric/duodenal ulcer
- Patient who received esophagus, stomach or duodenum surgery
- Patient with hypersensitivity to esomezol®
- Patient with no achieved agreement on the study from the guardian or patient himself.
Trial locations and contacts
1 site in 1 country.
About this study
For ERD(erosive reflux disease), which pathogenesis is mainly the acid reflux mechanism, primary treatment is therefore PPI. However, NERD(non-erosive reflux disease) is much more complex than ERD and there are more factors causing the typical symptoms. As a result, there is no consensus for the treatment of NERD besides using PPI similar to GERD(gastroesophageal reflux diseas). This study intent to evaluate the effect of PPI(Esomezol) on NERD patients and analyze the improvement of symptoms and the factors related to the result.
Read the detailed description
(1) Among GERD patients, EGD(esophagogastroduodenoscopy) must be done before 6 months and must prove there is no erosive lesion. (2) During EGD, esophagus mucosa histology will be taken for evaluation. (3) For NERD patients, Esomezol is given once a day (before breakfast meal), for whole 8 weeks. (4) PAGI-SYM and HAD-K is evaluated and score just before the administration of PPI, 4weeks after and 8weeks after the study initiation.
- Being tested
- PPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPIDrug
Also called Esomezol®
After the diagnosis of NERD through patient's symptom and endoscopy, PPI (esomezol) will be given for 8 weeks. The effect of PPI for NERD patients will be analyzed.
| Study group | Role | What they receive |
|---|---|---|
| PPI | Experimental | Esomezol® Receives: Drug: PPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of PAGI-SYM score (0-2) patients after 8 weeks of PPI(Esomezol)
Scoring the PAGI-SYM to analyze the satisfaction of symptoms (heartburn and regurgitation) after 8 weeks of PPI administration to NERD patients
Measured: 8 weeks
Secondary outcomes (1)
The analysis of factors affecting the PAGI-SYM inculding immunolgic array and esophagus mucosal microbiota
The analysis of complete symptom (regurgitation, heartburn) remission (PAGI-SYM score 0) after 8weeks of PPI
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Sep 2018
- Primary completion18 Oct 2019
- Study completion18 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-erosive Gatroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- There is only one arm in this study. Patients diagnosed as NERD will take PPI (Esomezol) for 8 weeks.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436914
- Sponsor's protocol ID
- 4-2017-1143
- Status last verified
- Dec 2019
- First submitted
- 12 Feb 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT03436914
- Acronym / sponsor ID
- 4-2017-1143
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 19 Feb 2018 (actual)
- 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.
For ERD(erosive reflux disease), which pathogenesis is mainly the acid reflux mechanism, primary treatment is therefore PPI. However, NERD(non-erosive reflux disease) is much more complex than ERD and there are more factors causing the typical symptoms. As a result, there is no consensus for the treatment of NERD besides using PPI similar to GERD(gastroesophageal reflux diseas). This study intent to evaluate the effect of PPI(Esomezol) on NERD patients and analyze the improvement of symptoms and the factors related to the result.
Detailed description
(1) Among GERD patients, EGD(esophagogastroduodenoscopy) must be done before 6 months and must prove there is no erosive lesion. (2) During EGD, esophagus mucosa histology will be taken for evaluation. (3) For NERD patients, Esomezol is given once a day (before breakfast meal), for whole 8 weeks. (4) PAGI-SYM and HAD-K is evaluated and score just before the administration of PPI, 4weeks after and 8weeks after the study initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There is only one arm in this study. Patients diagnosed as NERD will take PPI (Esomezol) for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| PPI | Experimental | Drug: PPIEsomezol® |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient over 19 years old
- Patient with typical GERD symptom (heartburn or acid reflux more than once a week)
Key exclusion criteria (5 listed)
- Patient who received EGD since the past 6 months, and diagnosed as GERD endoscopically
- Patient with active gastric/duodenal ulcer
- Patient who received esophagus, stomach or duodenum surgery
- Patient with hypersensitivity to esomezol®
- Patient with no achieved agreement on the study from the guardian or patient himself.
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 |
|---|---|---|
| PPIAlso: Esomezol®After the diagnosis of NERD through patient's symptom and endoscopy, PPI (esomezol) will be given for 8 weeks. The effect of PPI for NERD patients will be analyzed. | Drug | PPI |
Primary outcome
Proportion of PAGI-SYM score (0-2) patients after 8 weeks of PPI(Esomezol)
Time frame: 8 weeks
Scoring the PAGI-SYM to analyze the satisfaction of symptoms (heartburn and regurgitation) after 8 weeks of PPI administration to NERD patients
1 secondary outcome
The analysis of factors affecting the PAGI-SYM inculding immunolgic array and esophagus mucosal microbiota
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PPI in people with Non-erosive Gatroesophageal Reflux Disease, run by Yonsei University 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of PAGI-SYM score (0-2) patients after 8 weeks of PPI(Esomezol) (time frame: 8 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 2 Jan 2020.