The purpose of this survey is to evaluate the safety and effectiveness of vonoprazan tablets in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting.
The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat patients who have gastric ulcer, duodenal ulcer, and reflux esophagitis. This survey will look at the safety and effectiveness of vonoprazan in patients with gastric ulcer, duodenal ulcer, and reflux esophagitis in the routine clinical setting. The survey will enroll approximately 3000 participants. \- Vonoprazan 20 mg This multi-center survey will be conducted in Japan.
Study Type
OBSERVATIONAL
Enrollment
3,183
Vonoprazan tablets
Takeda Selected Site
Tokyo, Japan
Percentage of Participants With Gastric Ulcer 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 the administered drug.
Time frame: Up to 8 weeks
Percentage of Participants With Duodenal Ulcer Who Had One or More Adverse Drug Reactions
An 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 the administered drug.
Time frame: Up to 6 weeks
Percentage of Participants With Reflux Esophagitis Who Had One or More Adverse Drug Reactions
An 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 the administered drug.
Time frame: Up to 8 weeks
Endoscopic Cure Rate in Participants With Gastric Ulcer
Endoscopic cure rate was defined as a percentage of participants treated for gastric ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2.
Time frame: Up to 8 weeks
Endoscopic Cure Rate in Participants With Duodenal Ulcer
Endoscopic cure rate was defined as a percentage of participants treated for duodenal ulcer who classified as Scarring stage at the end of survey per Sakita-Miwa Classification. Endoscopic findings of ulcer were classified per Sakita-Miwa Classification as follows; Active stage: A1 and A2, Healing stage: H1 and H2, Scarring stage: S1 and S2.
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Time frame: Up to 6 weeks
Endoscopic Cure Rate in Participants With Reflux Esophagitis
Endoscopic cure rate was defined as a percentage of participants who treated for reflux esophagitis and met the criteria of Grade N or M in the modified Los Angeles (LA) classification at the end of survey. Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity.
Time frame: Up to 8 weeks
Percentage of Participants With Gastric Ulcer Whose Subjective Symptoms Improved
Percentage of participants who treated for gastric ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved".
Time frame: Baseline and at the end of the survey (up to 8 weeks)
Percentage of Participants With Duodenal Ulcer Whose Subjective Symptoms Improved
Percentage of participants who treated for duodenal ulcer and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved".
Time frame: Baseline and at the end of the survey (up to 6 weeks)
Percentage of Participants With Reflux Esophagitis Whose Subjective Symptoms Improved
Percentage of participants who treated for reflux esophagitis and whose subjective symptoms, including heartburn, acid reflux, postprandial fullness, early satiation, epigastric pain, epigastric burning, abdominal bloating, nausea/vomiting, belching and anorexia, were improved was reported. Presence or absence and severity of subjective symptoms were graded as asymptomatic, mild (occasionally or slightly symptomatic), moderate (considerably symptomatic), and severe (unendurably symptomatic). Participants with whose subjective symptom was improved by one grade or better were defined as "Improved".
Time frame: Baseline and at the end of the survey (up to 8 weeks)