Gastro-esophageal Reflux DiseaseNCT03824548
Outcomes for Patients With Gastro-Esophageal Reflux Disease
An observational study of Gastro-esophageal Reflux Disease, run by Tianjin Happy Life Technology Co., Ltd. at 1 site in China.
Trial summary
Gastro-esophageal reflux disease (GERD), the most common cause of erosive esophagitis (EE), remains highly prevalent worldwide. GERD poses substantial burden on both patients and society. EE treatment patterns and unmet needs have been well-studied overseas, but evidence gaps still exist in China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastro-esophageal Reflux Disease
- How many people
- 50,000 participants
- Where
- 1 siteChina
- Study dates
- 17 Jan 2019to 1 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The overall analysis population will consist of patients of all ages who were diagnosed with GERD from January 2015 to December 2017.
Who may be able to join
- Medical records of GERD, NERD and/or EE diagnoses （ICD code scope will be confirmed later）from January 1st, 2015 to December 31st, 2017.
- oGERD is typically characterized by symptoms of heartburn and acid regurgitation. A diagnosis of EE or NERD can only be confirmed upon endoscopic examination.
- All ages, males or females
- A primary diagnosis of GERD/NERD/EE
- For treatment patterns, patients are also required to have received one episode of treatment during the analysis period.
- For RW treatment efficacy, the population will be restricted to the EE treatment population who underwent at least two endoscopy examinations.
Who cannot join
- No exclusion criteria will be applied for investigating diagnosis since all patients diagnosed with GERD, NERD, or EE should be captured regardless of whether they have medical conditions that affect their treatments.
- A patient will not be eligible for investigating treatment patterns and RW treatment efficacy if he/she has any of the following exclusion criterion:
- A post-operative diagnosis of gastrointestinal cancers
- A diagnosis of esophageal foreign bodies or neoplasms
- A history of gastric or esophageal surgery
- Zollinger-Ellison syndrome
Show all 11Show fewer
- Primary esophageal motility disorders (ex: achalasia)
- Esophageal strictures
- Eosinophilic esophagitis
- Identified as pregnant or lactating
- Hospitalized (inpatient) patients (to be confirmed by expert.) due to GERD as primary or secondary diagnosis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yuan Na
Beijing, Beijing Municipality, 100000
Yuan Na, master, 13911152732, na.yuan@yiducloud.cn
About this study
Official title: Real-World Analysis on the Diagnosis, Treatment Pattern and Outcomes for Patients With Gastro-Esophageal Reflux Disease (GERD) in China
Gastro-esophageal reflux disease (GERD), the most common cause of erosive esophagitis (EE), remains highly prevalent worldwide.
GERD poses substantial burden on both patients and society. EE treatment patterns and unmet needs have been well-studied overseas, but evidence gaps still exist in China.
Read more
To fill these evidence gaps, real-world evidence for GERD and EE are needed. To understand GERD market we will analysis :Patient profile,GERD patient journey within hospital (first present, get diagnosed, receive initial and maintenance treatment),medication cost,department differentiation.
To investigate current treatment patterns of GERD / EE in China we will analysis: Current agents used and treatment duration in clinical practice treatment patterns by different reimbursement status treatment pattern by EE/NERD.
To get healing rate of EE we will analysis: Real-world efficacy of the current standard treatment (i.e. PPIs) for patient with two test results of gastroscopy.
The data required for this project are accessible in hospital electronic system; no specific data collection tools or methods are required for this project design. Only algorithms for retrieving and extracting eligible patients' records are required and will be developed by HLT based on the eligibility criteria defined in this protocol.
- Conditions
- Gastro-esophageal Reflux Disease
- Being tested
- this is non-intervention study, there is no intervention drug or device in this study.
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
this is non-intervention study, there is no intervention drug or device in this study.Other
this is exactly a non-interventional study, no intervention during the whole study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of GERD patients with an EE diagnosis confirmed by physician judgment vs. endoscopy
oAnalysis can be stratified by age group, sex, and health plan type to investigate possible differences in diagnostic practices based on these related patient characteristics.
Measured: oOnly patients diagnosed between January 1st, 2015 and October 31st, 2017 will be included to allow for at least an 8-week observational period.
Secondary outcomes (1)
Similarly, descriptive statistics will also be presented for secondary endpoints as the analysis further examines treatment use and proxy indicators assessing real-world treatment efficacy.
Proportion of EE patients and NERD patients by treatment use
Measured: Only patients diagnosed between January 1st, 2015 and October 31st, 2017 will be included to allow for at least an 8-week observational period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start17 Jan 2019
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-esophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Happy Life Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824548
- Sponsor's protocol ID
- HLT-RWE-GERD-001
- Status last verified
- Jan 2019
- First submitted
- 29 Jan 2019
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Analysis on the Diagnosis, Treatment Pattern and Outcomes for Patients With Gastro-Esophageal Reflux Disease (GERD) in China
- ClinicalTrials.gov ID
- NCT03824548
- Acronym / sponsor ID
- HLT-RWE-GERD-001
- Conditions
- Gastro-esophageal Reflux Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Tianjin Happy Life Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastro-esophageal reflux disease (GERD), the most common cause of erosive esophagitis (EE), remains highly prevalent worldwide.
GERD poses substantial burden on both patients and society. EE treatment patterns and unmet needs have been well-studied overseas, but evidence gaps still exist in China.
To fill these evidence gaps, real-world evidence for GERD and EE are needed. To understand GERD market we will analysis :Patient profile,GERD patient journey within hospital (first present, get diagnosed, receive initial and maintenance treatment),medication cost,department differentiation.
To investigate current treatment patterns of GERD / EE in China we will analysis: Current agents used and treatment duration in clinical practice treatment patterns by different reimbursement status treatment pattern by EE/NERD.
To get healing rate of EE we will analysis: Real-world efficacy of the current standard treatment (i.e. PPIs) for patient with two test results of gastroscopy.
The data required for this project are accessible in hospital electronic system; no specific data collection tools or methods are required for this project design. Only algorithms for retrieving and extracting eligible patients' records are required and will be developed by HLT based on the eligibility criteria defined in this protocol.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The overall analysis population will consist of patients of all ages who were diagnosed with GERD from January 2015 to December 2017.
Key inclusion criteria (6 listed)
- Medical records of GERD, NERD and/or EE diagnoses （ICD code scope will be confirmed later）from January 1st, 2015 to December 31st, 2017.
- oGERD is typically characterized by symptoms of heartburn and acid regurgitation. A diagnosis of EE or NERD can only be confirmed upon endoscopic examination.
- All ages, males or females
- A primary diagnosis of GERD/NERD/EE
- For treatment patterns, patients are also required to have received one episode of treatment during the analysis period.
Key exclusion criteria (11 listed)
- No exclusion criteria will be applied for investigating diagnosis since all patients diagnosed with GERD, NERD, or EE should be captured regardless of whether they have medical conditions that affect their treatments.
- A patient will not be eligible for investigating treatment patterns and RW treatment efficacy if he/she has any of the following exclusion criterion:
- A post-operative diagnosis of gastrointestinal cancers
- A diagnosis of esophageal foreign bodies or neoplasms
- A history of gastric or esophageal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| this is non-intervention study, there is no intervention drug or device in this study.this is exactly a non-interventional study, no intervention during the whole study. | Other | – |
Primary outcome
Proportion of GERD patients with an EE diagnosis confirmed by physician judgment vs. endoscopy
Time frame: oOnly patients diagnosed between January 1st, 2015 and October 31st, 2017 will be included to allow for at least an 8-week observational period.
oAnalysis can be stratified by age group, sex, and health plan type to investigate possible differences in diagnostic practices based on these related patient characteristics.
1 secondary outcome
Similarly, descriptive statistics will also be presented for secondary endpoints as the analysis further examines treatment use and proxy indicators assessing real-world treatment efficacy.
Time frame: Only patients diagnosed between January 1st, 2015 and October 31st, 2017 will be included to allow for at least an 8-week observational period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro-esophageal Reflux Disease, run by Tianjin Happy Life Technology Co., Ltd. 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 31 Jan 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of GERD patients with an EE diagnosis confirmed by physician judgment vs. endoscopy (time frame: oOnly patients diagnosed between January 1st, 2015 and October 31st, 2017 will be included to allow for at least an 8-week observational period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2019.