- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02984930
Effect of Proton Pump Inhibitor and Mosapride on Acid Pocket in Gastroesophageal Reflux Disease
December 6, 2016 updated by: Hyojin Park, Gangnam Severance Hospital
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 Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hyojin Park, MD, PhD
- Phone Number: 82-2019-4624
- Email: gnocr@yuhs.ac
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PPI + mosapride group
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.
|
Esomeprazole(Hanxium®) 40 mg once daily and mosapride (Gasmotin®) 5 mg t.i.d for 4 weeks.
After medication(4weeks), subjects will be undergo upper endoscopy and scintigraphy.
|
Placebo Comparator: PPI + placebo group
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.
|
After medication(4weeks), subjects will be undergo upper endoscopy and scintigraphy.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
|
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)
|
After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of reflux symptom
Time Frame: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
|
Using RDQ(Reflux Disease Questionnaire)
|
After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Anticipated)
July 1, 2018
Study Completion (Anticipated)
July 1, 2018
Study Registration Dates
First Submitted
August 23, 2016
First Submitted That Met QC Criteria
December 6, 2016
First Posted (Estimate)
December 7, 2016
Study Record Updates
Last Update Posted (Estimate)
December 7, 2016
Last Update Submitted That Met QC Criteria
December 6, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Esophagitis
- Peptic Ulcer
- Duodenal Diseases
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Serotonin Agents
- Serotonin Receptor Agonists
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Esomeprazole
- Mosapride
Other Study ID Numbers
- 3-2016-0071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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