CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 374 enrolled
Drug / intervention
Esomeprazole MUPS, 20 mgdrug
Likely dose
Esomeprazole MUPS, 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02506634
NCT02506634N/ACompleted

The Primary Symptoms of GERD in Chinese Outpatients in Gastroenterology Department: A Cross-sectional Investigation

First Affiliated Hospital, Sun Yat-Sen University·observational·Posted Jul 23, 2015·Updated Jan 13, 2020

In Brief

An observational study evaluating Esomeprazole MUPS, 20 mg for Gastroesophageal Reflux. Completed, enrolled 374 participants across 1 site.

Detailed Summary

Consecutive patients aged 18-65 years who go to the gastroenterology clinic presented with upper gastrointestinal discomfort would be included. All patients underwent upper endoscopy or an ambulatory 24-h pH(Potential Of Hydrogen) monitoring.Pathologic esophageal acid reflux was defined as the percentage total time for which a pH value \< 4 was \>4.2 % in the distal esophagus. Then, patients were treated with esomeprazole 20 mg twice daily for 28 days. The symptom scores were measured by the frequency score multiplied by the severity scores of the predominant symptom before and at the end of the treatment, and the " PPI test " was defined as positive if the overall scores of the predominant dyspeptic symptom in the fourth week decreased by \>50 % compared with those of the baseline. GERD is defined by either 24-hour impedance-pH monitoring or positive PPI(proton pump inhibitor) test or positive result from endoscopy. The percentage of each symptom of GERD in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated. The symptom of the highest percentage will be the primary symptom.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 23, 2015
Enrollment StartAug 1, 2015
Primary CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.9 years ago

Interventions

Esomeprazole MUPS, 20 mgdrug

According to the guidelines, the PPI treatment duration would be 8 weeks(Esomeprazole MUPS, 20 mg bid) for patients with reflux esophagitis and 4 weeks (Esomeprazole MUPS, 20 mg bid) for patients with normal findings on endoscopy.