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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,237
Vonoprazan tablets
Takeda Selected Site
Tokyo, Japan
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.
Time frame: Up to 12 months
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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Month 6 and at Month 12