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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080223147

Enrollment

1237

Registered

2016-03-16

Start date

2016-03-01

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

Reflux Esophagitis

Interventions

investigational material(s) Generic name etc : Vonoprazan 10 mg or 20 mg INN of investigational material : Vonoprazan Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants who require maintenance therapy for relapsed/recurrent reflux esophagitis.

Exclusion criteria

Exclusion criteria: 1. 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. 2. Participants with a previous history of hypersensitivity to ingredients in vonoprazan tablets. 3. Participants taking atazanavir sulfate or rilpivirine hydrochloride.

Design outcomes

Primary

Measure	Time frame
safety Percentage of Participants Who Had One or More Adverse Drug Reactions Timeframe: Up to 12 months 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.	—

Secondary

Measure	Time frame
efficacy Endoscopic Relapse Rate Timeframe: From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months 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 C: confluent mucosal breaks =75% circumferential. efficacy Number of Participants with Recorded Severity of Subjective Symptoms of Heartburn Timeframe: Baseline, Month 6 and at Month 12 Number of participants who had mild, moderate, or severe heartburn at each time points were reported. efficacy Number of Participants with Recorded Severity of Subjective Symptoms of Acid Reflux Timeframe: Baseline, Month 6 and at Month 12 Number of participants who had mild, moderate, or severe acid reflux at each time points were reported. efficacy Number of Participants with Recorded Severity of Subjective Symptoms of Postprandial Fullness Timeframe: Baseline, Month 6 and at Month 12 Number of participants who had mild, moderate, or severe postprandial fullness at each time points were reported. efficacy Number of Participants with Recorded Severity of Subjective Symptoms of Early Satiation Timeframe: Baseline, Month 6 and at Month 12 Number of participants who had mild, moderate, or severe early satiation at each time points were reported. efficacy Number of Participants with Recorded Severity of Subjective Symptoms of Epigastric Pain Timeframe: Baseline, Month 6 and at Month 12 Number of participants who had mild, moderate, or severe epigastric pain at each time points were reported. efficacy Number of Participants with Recorded Severity of Subjective Symptoms of Epigastric Burning Timeframe: Baseline, Month 6 and at Month 12 Number of par	—

Measure

Time frame

efficacy Endoscopic Relapse Rate Timeframe: From the initiation of the maintenance therapy to Month 12 (or discontinuation of the therapy), up to 12 months 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 C: confluent mucosal breaks =75% circumferential. efficacy Number of Participants with Recorded Severity of Subjective Symptoms of Heartburn Timeframe: Baseline, Month 6 and at Month 12 Number of participants who had mild, moderate, or severe heartburn at each time points were reported. efficacy Number of Participants with Recorded Severity of Subjective Symptoms of Acid Reflux Timeframe: Baseline, Month 6 and at Month 12 Number of participants who had mild, moderate, or severe acid reflux at each time points were reported. efficacy Number of Participants with Recorded Severity of Subjective Symptoms of Postprandial Fullness Timeframe: Baseline, Month 6 and at Month 12 Number of participants who had mild, moderate, or severe postprandial fullness at each time points were reported. efficacy Number of Participants with Recorded Severity of Subjective Symptoms of Early Satiation Timeframe: Baseline, Month 6 and at Month 12 Number of participants who had mild, moderate, or severe early satiation at each time points were reported. efficacy Number of Participants with Recorded Severity of Subjective Symptoms of Epigastric Pain Timeframe: Baseline, Month 6 and at Month 12 Number of participants who had mild, moderate, or severe epigastric pain at each time points were reported. efficacy Number of Participants with Recorded Severity of Subjective Symptoms of Epigastric Burning Timeframe: Baseline, Month 6 and at Month 12 Number of par

—

Countries

Japan

Outcome results

None listed

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