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Outcomes for Patients With Gastro-Esophageal Reflux Disease

Real-World Analysis on the Diagnosis, Treatment Pattern and Outcomes for Patients With Gastro-Esophageal Reflux Disease (GERD) in China

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03824548
Enrollment
50000
Registered
2019-01-31
Start date
2019-01-17
Completion date
2019-05-01
Last updated
2019-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-esophageal Reflux Disease

Brief 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. 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.

Interventions

OTHERthis 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.

Sponsors

Tianjin Happy Life Technology Co., Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

\- No

Design outcomes

Primary

MeasureTime frameDescription
Proportion of GERD patients with an EE diagnosis confirmed by physician judgment vs. endoscopyoOnly 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.

Secondary

MeasureTime frameDescription
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.Only patients diagnosed between January 1st, 2015 and October 31st, 2017 will be included to allow for at least an 8-week observational period.Proportion of EE patients and NERD patients by treatment use

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026