The Primary Symptoms of GERD(Gastroesophageal Reflux Disease) in Chinese Outpatients in Gastroenterology Department

Sun Yat-sen University

Status: Completed

Conditions: Gastroesophageal Reflux

Treatments: Drug: Esomeprazole MUPS, 20 mg

Study type: Observational

Funder types: Other

Identifiers

NCT02506634

ESR-14-10521

Details and patient eligibility

About

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.

Full description

Primary Objective：To define the primary symptom of GERD in Chinese outpatients in Gastroenterology department Secondary Objective：1. To investigate the symptom distribution of patients who present with symptoms originated from upper gastrointestinal tract and have pathologic esophageal reflux established by 24-hour impedance-pH monitoring, upper endoscopy, or proton pump inhibitor test.

2. To evaluate the life quality of patients with atypical GERD symptoms (symptoms except heartburning and regurgitation) 3. To investigate the diagnostic value of proton pump inhibitor trial to diagnose GERD with atypical reflux symptoms 4. To investigate the predictive value of Gerd Q to diagnose GERD with atypical reflux symptoms with heartburn or regurgitation

Enrollment: 374 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive patients aged 18-65 years who go to the gastroenterology clinic presented with upper gastrointestinal discomfort, such as heartburn, regurgitation, dysphagia, substernal pain, epigastric pain, epigastric burning, early satiety, postprandial fullness.
• Whose previous symptoms should last for at least 3 months and be at least 3 days per week in frequency with moderate severity.
• Able to fill in the questionaires.

Exclusion criteria

• gastric or duodenal ulcers, upper GI neoplasms on upper endoscopy
• severe cardiac or pulmonary diseases, diabetes or rheumatic diseases
• history of operations in the upper GI tract
• renal failure or abnormal liver function
• use of non-steroidal anti-inflammatory drugs (NSAIDs)
• allergy to esomeprazole
• Pregnancy or lactating mother

Trial design

374 participants in 1 patient group

Participants with upper gastrointestinal symptoms

Description:

Participants are stratified at baseline based on their main upper gastrointestinal symptoms and then evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). Patients would then be given Esomeprazole MUPS（ Multiple Unit Pellet System）20 mg bid for evaluating the ability of the PPI Test for GERD. According to the guidelines, the duraion of PPI treatment was 4 weeks and 8 weeks for endoscopy negative patients and patients has reflux esophagitis, respectively.

Treatment:

Drug: Esomeprazole MUPS, 20 mg