Gastroesophageal Reflux DiseaseNCT02984930
Effect of Proton Pump Inhibitor and Mosapride on Acid Pocket in Gastroesophageal Reflux Disease
A study testing Administration of study drug (esomeprazole, mosapride) and upper endoscopy, scintigraphy in people with Gastroesophageal Reflux Disease, run by Gangnam Severance Hospital.
Trial summary
The gastric acid pocket is believed to be the reservoir from which acid reflux events originate. The risk for acidic reflux is mainly determined by the position of the gastric acid pocket. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Administration of study drug (esomeprazole, mosapride) and upper endoscopy, scintigraphy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jul 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with diagnosed GERD(gastro-esophageal reflux disease), defined by the presence of oesophagitis obtained during a previous upper endoscopy or typical GERD symptoms(heartburn, acid reflux).
Who cannot join
- who had organic gastrointestinal disease including inflammatory bowel disease, cancer and ulcer
- who took drugs which could affect evaluation of the treatment; other PPIs, H2RAs(H2 receptor antagonists), prokinetics,mucosal protective agents, antacids, cholinergic and anticholinergic agents, and antidepressants for at least 4 weeks prior to study start
- who had severe systemic diseases including hepatic and nephrotic disease
- who had previous gastrectomy history
- who was in state of pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
The gastric acid pocket is believed to be the reservoir from which acid reflux events originate. The risk for acidic reflux is mainly determined by the position of the gastric acid pocket. Little is known about how changes in position and size of the acid pocket contribute to the therapeutic effect of proton pump inhibitors(PPI) plus mosapride in patients with gastroesophageal reflux disease. Investigators will conduct a prospective randomized, single blind and placebo-controlled clinical trial to evaluate the hypothesis that mosapride affecting gastric motility might reduce gastro-esophageal reflux by changing the acid pocket position and size.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Administration of study drug (esomeprazole, mosapride), Administration of study drug (esomeprazole, placebo tablet), upper endoscopy, scintigraphy
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of study drug (esomeprazole, mosapride)Drug
Esomeprazole(Hanxium®) 40 mg once daily and mosapride (Gasmotin®) 5 mg t.i.d for 4 weeks.
Administration of study drug (esomeprazole, placebo tablet)Drug
Esomeprazole(Hanxium®) 40 mg once daily and placebo tablets that are identical to mosapride tablets t.i.d (3 times a day) for 4 weeks.
upper endoscopy, scintigraphyProcedure or surgery
After medication(4weeks), subjects will be undergo upper endoscopy and scintigraphy.
| Study group | Role | What they receive |
|---|---|---|
| PPI + mosapride group | Experimental | After diagnosis(GERD), patient of this group will be taken proton pump inhibitor (40mg) plus mosapride for 4weeks. After then, patient of this group will be undergo upper endoscopy and scintigraphy. Receives: Drug: Administration of study drug (esomeprazole, mosapride); Procedure: upper endoscopy, scintigraphy |
| PPI + placebo group | Placebo comparator | After diagnosis(GERD), patient of this group will be taken proton pump inhibitor (40mg) plus placebo drug of mosapride for 4weeks. After then, patient of this group will be undergo upper endoscopy and scintigraphy. Receives: Drug: Administration of study drug (esomeprazole, placebo tablet); Procedure: upper endoscopy, scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size(cm2) of the acid pocket between PPI+placebo group and PPI+mosapride group
The size of the acid pocket will be determined by drawing an area of interest over the acid pocket in the proximal stomach in images(scintigraphy) taken at 10-minute intervals.
Measured: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
Location(cm) of the acid pocket between PPI+placebo group and PPI+mosapride group
Measurements of the distances between the acid pocket and the diaphragm will be make through a straight line in a planar posterior view of the stomach in images(scintigraphy)
Measured: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
Secondary outcomes (1)
Improvement of reflux symptom
Using RDQ(Reflux Disease Questionnaire)
Measured: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyojin Park, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984930
- Sponsor's protocol ID
- 3-2016-0071
- Status last verified
- Aug 2016
- First submitted
- 23 Aug 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Proton Pump Inhibitor and Mosapride on Acid Pocket in Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT02984930
- Acronym / sponsor ID
- 3-2016-0071
- Conditions
- Gastroesophageal Reflux Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 7 Dec 2016 (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.
The gastric acid pocket is believed to be the reservoir from which acid reflux events originate. The risk for acidic reflux is mainly determined by the position of the gastric acid pocket. Little is known about how changes in position and size of the acid pocket contribute to the therapeutic effect of proton pump inhibitors(PPI) plus mosapride in patients with gastroesophageal reflux disease. Investigators will conduct a prospective randomized, single blind and placebo-controlled clinical trial to evaluate the hypothesis that mosapride affecting gastric motility might reduce gastro-esophageal reflux by changing the acid pocket position and size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPI + mosapride group | Experimental | Drug: Administration of study drug (esomeprazole, mosapride), Procedure: upper endoscopy, scintigraphyAfter diagnosis(GERD), patient of this group will be taken proton pump inhibitor (40mg) plus mosapride for 4weeks. After then, patient of this group will be undergo upper endoscopy and scintigraphy. |
| PPI + placebo group | Placebo comparator | Drug: Administration of study drug (esomeprazole, placebo tablet), Procedure: upper endoscopy, scintigraphyAfter diagnosis(GERD), patient of this group will be taken proton pump inhibitor (40mg) plus placebo drug of mosapride for 4weeks. After then, patient of this group will be undergo upper endoscopy and scintigraphy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with diagnosed GERD(gastro-esophageal reflux disease), defined by the presence of oesophagitis obtained during a previous upper endoscopy or typical GERD symptoms(heartburn, acid reflux).
Key exclusion criteria (5 listed)
- who had organic gastrointestinal disease including inflammatory bowel disease, cancer and ulcer
- who took drugs which could affect evaluation of the treatment; other PPIs, H2RAs(H2 receptor antagonists), prokinetics,mucosal protective agents, antacids, cholinergic and anticholinergic agents, and antidepressants for at least 4 weeks prior to study start
- who had severe systemic diseases including hepatic and nephrotic disease
- who had previous gastrectomy history
- who was in state of pregnancy
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 |
|---|---|---|
| Administration of study drug (esomeprazole, mosapride)Esomeprazole(Hanxium®) 40 mg once daily and mosapride (Gasmotin®) 5 mg t.i.d for 4 weeks. | Drug | PPI + mosapride group |
| Administration of study drug (esomeprazole, placebo tablet)Esomeprazole(Hanxium®) 40 mg once daily and placebo tablets that are identical to mosapride tablets t.i.d (3 times a day) for 4 weeks. | Drug | PPI + placebo group |
| upper endoscopy, scintigraphyAfter medication(4weeks), subjects will be undergo upper endoscopy and scintigraphy. | Procedure or surgery | PPI + mosapride group, PPI + placebo group |
Primary outcome
Size(cm2) of the acid pocket between PPI+placebo group and PPI+mosapride group
Time frame: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
The size of the acid pocket will be determined by drawing an area of interest over the acid pocket in the proximal stomach in images(scintigraphy) taken at 10-minute intervals.
Location(cm) of the acid pocket between PPI+placebo group and PPI+mosapride group
Time frame: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
Measurements of the distances between the acid pocket and the diaphragm will be make through a straight line in a planar posterior view of the stomach in images(scintigraphy)
1 secondary outcome
Improvement of reflux symptom
Time frame: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of study drug (esomeprazole, mosapride) and upper endoscopy, scintigraphy in people with Gastroesophageal Reflux Disease, run by Gangnam Severance Hospital.
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 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: status not confirmed, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Hyojin Park, MD, PhD (82-2019-4624, gnocr@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size(cm2) of the acid pocket between PPI+placebo group and PPI+mosapride group (time frame: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)). The study lists 2 primary outcomes in all. 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 7 Dec 2016.