Special Drug Use Surveillance of Vonoprazan for Maintenance Therapy of Reflux Esophagitis: Long-term Use

Study Overview
=================
Brief Summary
-----------------
The purpose of this survey is to evaluate the safety and effectiveness of long-term administration of vonoprazan tablets when used as maintenance therapy for reflux esophagitis in routine clinical settings.

Detailed Description
-----------------
The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat patients who have reflux esophagitis. This survey will look at the safety and effectiveness of long-term administration of vonoprazan tablets when used as maintenance therapy for reflux esophagitis in routine clinical settings. The survey will enroll approximately 1000 participants. - Vonoprazan 10 mg or 20 mg This multi-center observational trial will be conducted in Japan.

Official Title
-----------------
Special Drug Use Surveillance of Takecab Tablets for Maintenance Therapy of Reflux Esophagitis: Long-term Use

Conditions
-----------------
Reflux Esophagitis

Intervention / Treatment
-----------------
* Drug: Vonoprazan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Participants who require maintenance therapy for relapsed/recurrent reflux esophagitis Exclusion Criteria: Participants meeting the criteria of grade A to D according to the Los Angeles classification (Hoshihara's modification), by means of endoscopy at the initiation of maintenance therapy with vonoprazan tablets Participants with a previous history of hypersensitivity to ingredients in vonoprazan tablets Participants taking atazanavir sulfate or rilpivirine hydrochloride
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vonoprazan 10 mg or 20 mg<br>Usually, for adults, 10 mg of vonoprazan administered orally once daily. If that dosing proved insufficient, the dosage may have been increased up to 20 mg once daily. Participants received vonoprazan as part of a routine medical care. | Drug: Vonoprazan<br>* Vonoprazan tablets<br>* Other names: TAK-438;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Had One or More Adverse Drug Reactions | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic Relapse Rate | Endoscopic relapse rate was defined as a percentage of participants who met the criteria of Grade A to D in the modified Los Angeles (LA) classification. The modified LA classification graded endoscopic findings as follows- Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity; Grade A: non-confluent mucosal breaks <5 mm in length; Grade B: nonconfluent mucosal breaks ≥ 5 mm in length; Grade C: confluent mucosal breaks <75% circumferential; Grade D: confluent mucosal breaks >=75% circumferential. | From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months | 
| Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe heartburn at each time points were reported. | Baseline, Month 6 and at Month 12 | 
| Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe acid reflux at each time points were reported. | Baseline, Month 6 and at Month 12 | 
| Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe postprandial fullness at each time points were reported. | Baseline, Month 6 and at Month 12 | 
| Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe early satiation at each time points were reported. | Baseline, Month 6 and at Month 12 | 
| Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe epigastric pain at each time points were reported. | Baseline, Month 6 and at Month 12 | 
| Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe epigastric burning at each time points were reported. | Baseline, Month 6 and at Month 12 | 
| Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe abdominal bloating at each time points were reported. | Baseline, Month 6 and at Month 12 | 
| Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe nausea/vomiting at each time points were reported. | Baseline, Month 6 and at Month 12 | 
| Number of Participants With Recorded Severity of Subjective Symptoms of Belching | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe belching at each time points were reported. | Baseline, Month 6 and at Month 12 | 
| Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia | Presence or absence and severity of subjective symptoms were collected from participants during medical interviews of each visit as none (asymptomatic), mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), severe (unendurably symptomatic), and unknown. Number of participants who had mild, moderate, or severe anorexia at each time points were reported. | Baseline, Month 6 and at Month 12 |