Drug Use Surveillance of Vonoprazan for "Gastric Ulcer, Duodenal Ulcer, and Reflux Esophagitis"

Drug use surveillance of Takecab tablets for "Gastric ulcer, duodenal ulcer, and reflux esophagitis"

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080223122

Enrollment

3183

Registered

2016-03-01

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

Gastric ulcer, duodenal ulcer, and reflux esophagitis

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Participants with gastric ulcer, duodenal ulcer, and reflux esophagitis

Exclusion criteria

Exclusion criteria: - Participants with previous history of hypersensitivity to ingredients in Takecab tablets - Participants taking atazanavir sulfate or rilpivirine hydrochloride - Participants meeting the criteria of scarring stage (S1, S2) of endoscopic classification defined by Sakita and Miwa at the start of the treatment with Takecab tablets, in the case that the target disease is gastric ulcer or duodenal ulcer - Participants meeting the criteria of Grade N or Grade M of Los Angeles classification (Hoshihara's modification) at the start of the treatment with Takecab tablets, in the case that the target disease is reflux esophagitis.

Design outcomes

Primary

Measure	Time frame
safety Percentage of Participants with Gastric Ulcer Who Had One or More Adverse Drug Reactions Time Frame: Up to 8 weeks 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. safety Percentage of Participants with Duodenal Ulcer Who Had One or More Adverse Drug Reactions Time Frame: Up to 6 weeks 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. safety Percentage of Participants with Reflux Esophagitis Who Had One or More Adverse Drug Reactions Time Frame: Up to 8 weeks 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.	—

Measure

Time frame

safety Percentage of Participants with Gastric Ulcer Who Had One or More Adverse Drug Reactions Time Frame: Up to 8 weeks 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. safety Percentage of Participants with Duodenal Ulcer Who Had One or More Adverse Drug Reactions Time Frame: Up to 6 weeks 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. safety Percentage of Participants with Reflux Esophagitis Who Had One or More Adverse Drug Reactions Time Frame: Up to 8 weeks 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.

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Secondary

Measure	Time frame
efficacy Endoscopic Cure Rate in Participants with Gastric Ulcer Time Frame: Up to 8 weeks Endoscopic cure rate was defined as a percentage of participants treated for gastric ulcer who classified as Scarring stage at the end of treatment period per Sakita-Miwa Classification. efficacy Endoscopic Cure Rate in Participants with Duodenal Ulcer Time Frame: Up to 6 weeks Endoscopic cure rate was defined as a percentage of participants treated for duodenal ulcer who classified as Scarring stage at the end of treatment period per Sakita-Miwa Classification. efficacy Endoscopic Cure Rate in Participants with Reflux Esophagitis Time Frame: Up to 8 weeks 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 treatment. Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity. efficacy Percentage of Participants with Gastric Ulcer whose Subjective Symptoms Improved Time Frame: Baseline and at the end of the survey (up to 8 weeks) 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. Subjective symptoms were graded as mild, moderate, and severe. Participants with whose subjective symptom was improved by one grade or better were defined as "Improved". efficacy Percentage of Participants with Duodenal Ulcer whose Subjective Symptoms Improved Time Frame: Baseline and at the end of the survey (up to 6 weeks) 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 anore	—

Measure

Time frame

efficacy Endoscopic Cure Rate in Participants with Gastric Ulcer Time Frame: Up to 8 weeks Endoscopic cure rate was defined as a percentage of participants treated for gastric ulcer who classified as Scarring stage at the end of treatment period per Sakita-Miwa Classification. efficacy Endoscopic Cure Rate in Participants with Duodenal Ulcer Time Frame: Up to 6 weeks Endoscopic cure rate was defined as a percentage of participants treated for duodenal ulcer who classified as Scarring stage at the end of treatment period per Sakita-Miwa Classification. efficacy Endoscopic Cure Rate in Participants with Reflux Esophagitis Time Frame: Up to 8 weeks 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 treatment. Grade N: normal mucosa; Grade M: minimal changes to the mucosa, such as erythema and/or whitish turbidity. efficacy Percentage of Participants with Gastric Ulcer whose Subjective Symptoms Improved Time Frame: Baseline and at the end of the survey (up to 8 weeks) 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. Subjective symptoms were graded as mild, moderate, and severe. Participants with whose subjective symptom was improved by one grade or better were defined as "Improved". efficacy Percentage of Participants with Duodenal Ulcer whose Subjective Symptoms Improved Time Frame: Baseline and at the end of the survey (up to 6 weeks) 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 anore

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Countries

Japan

Outcome results

None listed

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