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

Completed

Conditions: Reflux Esophagitis

Interventions: Drug: Vonoprazan

Registration Number: NCT03214081

Lead Sponsor: Takeda

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1237

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vonoprazan 10 mg or 20 mg	Vonoprazan	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Had One or More Adverse Drug Reactions	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 Outcome Measures

Name	Time	Method
Endoscopic Relapse Rate	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 B: nonconfluent mucosal breaks ≥ 5 mm in length; Grade C: confluent mucosal breaks \<75% circumferential; Grade D: confluent mucosal breaks \>=75% circumferential.
Number of Participants With Recorded Severity of Subjective Symptoms of Postprandial Fullness	Baseline, Month 6 and at Month 12	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.
Number of Participants With Recorded Severity of Subjective Symptoms of Heartburn	Baseline, Month 6 and at Month 12	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.
Number of Participants With Recorded Severity of Subjective Symptoms of Early Satiation	Baseline, Month 6 and at Month 12	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.
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Pain	Baseline, Month 6 and at Month 12	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.
Number of Participants With Recorded Severity of Subjective Symptoms of Abdominal Bloating	Baseline, Month 6 and at Month 12	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.
Number of Participants With Recorded Severity of Subjective Symptoms of Anorexia	Baseline, Month 6 and at Month 12	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.
Number of Participants With Recorded Severity of Subjective Symptoms of Acid Reflux	Baseline, Month 6 and at Month 12	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.
Number of Participants With Recorded Severity of Subjective Symptoms of Epigastric Burning	Baseline, Month 6 and at Month 12	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.
Number of Participants With Recorded Severity of Subjective Symptoms of Nausea/Vomiting	Baseline, Month 6 and at Month 12	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.
Number of Participants With Recorded Severity of Subjective Symptoms of Belching	Baseline, Month 6 and at Month 12	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.