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

Not Applicable

Completed

• Conditions: Gastric ulcer, duodenal ulcer, and reflux esophagitis

• Registration Number: JPRN-jRCT1080223122
• Lead Sponsor: Takeda Pharmaceutical Company Limited

Brief Summary

In conclusion, from the results stated above, this surveillance raised no new concerns about the safety or efficacy of Takecab Tablets in participants with gastric ulcer, duodenal ulcer, or reflux esophagitis. Please refer to conclusions of "Adverse Events" and "Secondary Outcome Measures" sections for the details.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-01
• Study Completion: 2018-10-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 3183

Inclusion Criteria

Participants with gastric ulcer, duodenal ulcer, and reflux esophagitis

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified