N/A
N=374
The Primary Symptoms of GERD(Gastroesophageal Reflux Disease) in Chinese Outpatients in Gastroenterology Department
Gastroesophageal Reflux
Bottom Line
View on ClinicalTrials.gov: NCT02506634 ↗Enrolled (actual)
374
Serious AEs
0.3%
Results posted
Dec 2019
Primary outcome: Primary: The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department — 19; 30; 42; 23 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Esomeprazole MUPS, 20 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department |
19; 30; 42; 23; 30; 38 | — |
| SECONDARY The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms |
19; 23; 9; 2; 9; 4 | — |
| SECONDARY The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms |
30; 30; 16; 4; 5; 11 | — |
| SECONDARY 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 |
565.04; 582.55; 606.35; 706.67; 581.15; 545.8 | — |
| SECONDARY The Sensitivity of PPI Test for Diagnosis of GERD |
0.64; 0.51 | — |
| SECONDARY The Specificity of PPI Test for Diagnosis of GERD |
0.40; 0.62 | — |
| SECONDARY The Sensitivity of GERDQ for Diagnosis of GERD |
0.84; 0.43 | — |
| SECONDARY The Specificity of GERDQ for Diagnosis of GERD |
0.24; 0.63 | — |
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 4.2 % 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.
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
Data sourced from ClinicalTrials.gov (NCT02506634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.