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

NCT ID: NCT02506634

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 374 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2019-01-31

Brief 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.

Detailed 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

Conditions

Gastroesophageal Reflux

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with upper gastrointestinal symptoms

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.

Esomeprazole MUPS, 20 mg

Intervention Type: DRUG

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.

Interventions

Esomeprazole MUPS, 20 mg

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.

Intervention Type: DRUG

Other Intervention Names

Nexium

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

tanniandi

Resident physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Minhu Chen, PHD

Role: STUDY_DIRECTOR

vice-president of the first Affiliated hospital of SYSU

Locations

the first affiliated hospital of SYSU

Guangzhou, Guangdong, China

Countries

China

References

Zhang MY, Tan ND, Li YW, Sifrim D, Pandolfino JE, Xiao YL, Chen MH. Esophageal symptoms versus epigastric symptoms: Relevance for diagnosis of gastroesophageal reflux disease. J Dig Dis. 2020 Dec;21(12):696-704. doi: 10.1111/1751-2980.12946. Epub 2020 Nov 8.

Reference Type: DERIVED

PMID: 32975045 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ESR-14-10521

Identifier Type: -

Identifier Source: org_study_id