AzTrials
AzTrials

Gastroesophageal RefluxNCT02506634

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

An observational study of Gastroesophageal Reflux, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Gastroesophageal Reflux
What is being tested?
Esomeprazole MUPS, 20 mg
How many people
374 participants
Where
1 siteChina
Study dates
Aug 2015to Jan 2019
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

China1 site

  • the first affiliated hospital of SYSU

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

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

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.

Read the 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.

  1. 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
Being tested
Esomeprazole MUPS, 20 mg
Keywords
symptom
Medical subject headings
Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Esomeprazole MUPS, 20 mgDrug

    Also called Nexium

    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.

Study groups in NCT02506634
Study groupRoleWhat they receive
Participants with upper gastrointestinal symptomsParticipants 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.
Receives: Drug: Esomeprazole MUPS, 20 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: over 3 years

Secondary outcomes (7)

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

    The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with different main symptom in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated.

    Measured: over 3 years

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

    The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with different main baseline symptom in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated.

    Measured: over 3 years

  3. 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

    The life quality of GERD patients with different main symptoms before PPI test will be measured via the MOS 36-item short form health survey (SF-36), in which higher scores mean a better quality of life. Its maximum score is 796.5, and the minimum score is 36.5.

    Measured: over 3 years

  4. The Sensitivity of PPI Test for Diagnosis of GERD

    The sensitivity of PPI test for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD.

    Measured: over 3 years

  5. The Specificity of PPI Test for Diagnosis of GERD

    The specificity of PPI test for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD.

    Measured: over 3 years

  6. The Sensitivity of GERDQ for Diagnosis of GERD

    The sensitivity of GERDQ for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD.

    Measured: over 3 years

  7. The Specificity of GERDQ for Diagnosis of GERD

    The specificity of GERDQ for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the "gold standard" for the diagnosis of GERD.

    Measured: over 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJan 2019
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
374 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02506634
Sponsor's protocol ID
ESR-14-10521
Status last verified
Dec 2019
First submitted
20 Jul 2015
Last updated
13 Jan 2020
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32975045

Questions about this trial

What is this clinical trial studying?

An observational study of Gastroesophageal Reflux, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department (time frame: over 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02506634, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in