Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1304 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-01

Study Completion Date

2020-04-30

Brief Summary

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The purpose of this study is to investigate the safety and efficacy of long-term administration of Vonoprazan tablets (Takecab tablets) for up to 12 months in the routine clinical setting in patients receiving non-steroidal anti-inflammatory drugs (NSAIDs).

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Detailed Description

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The drug being tested in this study is called Vonoprazan. Vonoprazan is being tested to treat people who have a history of gastric or duodenal ulcers.

This study will look at the safety and efficacy of long-term administration of Vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving NSAIDs.

The study will enroll approximately 1000 participants.

• Vonoprazan 10 mg

This multi-center observational survey will be conducted in Japan.

Conditions

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A History of Gastric or Duodenal Ulcers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vonoprazan 10 mg

The usual adult dosage for oral use is 10 mg of Vonoprazan administered once daily. Participants will receive interventions as part of routine medical care.

Vonoprazan

Intervention Type DRUG

Vonoprazan tablets

Interventions

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Vonoprazan

Vonoprazan tablets

Intervention Type DRUG

Other Intervention Names

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Takecab tablets TAK-438

Eligibility Criteria

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Inclusion Criteria

\- Participants with a history of gastric or duodenal ulcer

Exclusion Criteria

* Participants with gastric or duodenal ulcer at initiation of vonoprazan therapy
* Participants with active upper gastrointestinal haemorrhage at initiation of vonoprazan therapy
* Participants with a history of hypersensitivity to any ingredients of vonoprazan Tablets
* Participants receiving atazanavir sulfate or rilpivirine hydrochloride

Eligible Sex

ALL

Accepts Healthy Volunteers

No