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

NCT02506634 | Completed Results DMC

• 1 other identifier: ESR-14-10521
• Study Type: observational
• Target: 374
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux

Keywords

symptom

Outcome Measures

Primary Outcomes (1)

• The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department

  GERD can be diagnosed by more than one different criteria (i.e."reflux esophagitis on endoscopy"; "positive acid exposure time (AET) on reflux monitoring";"Either reflux esophagitis on endoscopy or positive AET on reflux monitoring") in a single participant. When different criteria was used to diagnose GERD, the percentage of GERD patients with different predominant symptom will be calculated. The symptom of the highest percentage will be the primary symptom.

  over 3 years

Secondary Outcomes (7)

• The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms

  over 3 years

• The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms

  over 3 years

• The Life Quality of GERD Patients Who Were Diagnosed by Either Reflux Esophagitis on Endoscopy or Positive Acid Exposure Time(AET) on Reflux Monitoring and Presented With Different Main Baseline Symptoms

  over 3 years

• The Sensitivity of PPI Test for Diagnosis of GERD

  over 3 years

• The Specificity of PPI Test for Diagnosis of GERD

  over 3 years

Study Arms (1)

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.

Drug: Esomeprazole MUPS, 20 mg

Interventions

Esomeprazole MUPS, 20 mg 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.

Also known as: Nexium

Participants with upper gastrointestinal symptoms

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be done in the outpatient clinic, department of Gastroenterology, first affiliated hospital, sun yet-sen university. Consecutive patients who met the inclusion criteria in the Gastroenterology clinic in the first affiliated hospital will be enrolled in the study. There will not be any randomization in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

the first affiliated hospital of SYSU

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• 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.

  PMID: 32975045 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Niandi Tan
• Organization: FirstSunYetSen

tanniandi@126.com

+86 15989117039

Study Officials

• Minhu Chen, PHD

  vice-president of the first Affiliated hospital of SYSU

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 23, 2015
• Study Start: August 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 13, 2020
• Results First Posted: December 4, 2019

Record last verified: 2019-12

Locations

CN (1)