GERD symptom scale study

Development of a Symptom Scale of Gastroesophageal Reflux Disease (GERD)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080223125

Enrollment

440

Registered

2016-03-02

Start date

2016-03-02

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Gastroesophageal Reflux Disease (GERD)

Interventions

investigational material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : - control material(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) [Common to Steps 1 to 3] 1.Patients who have been diagnosed with GERD (including reflux esophagitis and non-erosive gastroesophageal reflux disease) during routine medical care and have GERD symptoms 2.Male or female and is aged 20 years or older at the time of informed consent 2) [Step 1] Qualitative study (individual or group interview) 3.Patients capable of understanding the questions of the research team member or examiner and those capable of verbally explaining their own symptoms. 3) [Steps 2 and 3] Patients with untreated gastroesophageal reflux disease and are planning to undergo treatment with a proton pump inhibitor

Exclusion criteria

Exclusion criteria: 1.Patients strongly suspected of having ischemic heart disease 2.Patients strongly suspected of having asthma or chronic cough 3.Patients with obvious cognitive dysfunction that would affect the research

Design outcomes

Primary

Measure	Time frame
Reliability/validity/responsiveness to treatment of the developed symptom scale for GERD Reliability assessment:Reliability of measurements (for each domain) will be assessed by Cronbach's alpha coefficient and the amount of test information. Acceptable values for assessment are 0.8 and 8, respectively. Validity assessment: Concurrent validity will be demonstrated by correlations with existing scales. External criteria for validity assessment will be set as follows: SF36 Japanese version Bodily pain score, Role physical score, and Role emotional score, FSS Japanese version score, GSRS Japanese version score. Responsiveness assessment The mean change in the scale scores before and after treatment (compared with the interindividual variation) will be analyzed to determine if an assessment of treatment response is possible. For assessment of treatment response, standardized response mean (SRM defined as mean change in score/standard deviation of change) will be used and Cohen's criteria (0.2=small, 0.5=medium, 0.8 =large) will be used as criteria for the interpretation.	—

Measure

Time frame

Reliability/validity/responsiveness to treatment of the developed symptom scale for GERD Reliability assessment:Reliability of measurements (for each domain) will be assessed by Cronbach's alpha coefficient and the amount of test information. Acceptable values for assessment are 0.8 and 8, respectively. Validity assessment: Concurrent validity will be demonstrated by correlations with existing scales. External criteria for validity assessment will be set as follows: SF36 Japanese version Bodily pain score, Role physical score, and Role emotional score, FSS Japanese version score, GSRS Japanese version score. Responsiveness assessment The mean change in the scale scores before and after treatment (compared with the interindividual variation) will be analyzed to determine if an assessment of treatment response is possible. For assessment of treatment response, standardized response mean (SRM defined as mean change in score/standard deviation of change) will be used and Cohen's criteria (0.2=small, 0.5=medium, 0.8 =large) will be used as criteria for the interpretation.

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Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026