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

Not Applicable

Completed

• Conditions: Reflux Esophagitis

• Registration Number: JPRN-jRCT1080223147
• 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 long-term use of Takecab Tablets as maintenance therapy for 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: 2016-03-16
• Study Completion: 2018-08-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 1237

Inclusion Criteria

Participants who require maintenance therapy for relapsed/recurrent reflux esophagitis.

Exclusion Criteria

1. 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.
2. Participants with a previous history of hypersensitivity to ingredients in vonoprazan tablets.
3. Participants taking atazanavir sulfate or rilpivirine hydrochloride.

Study & Design

• Study Type: Observational
• Study Design: Not specified