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"

Completed

• Conditions: A History of Gastric or Duodenal Ulcers
• Interventions: Drug: Vonoprazan

• Registration Number: NCT03214198
• Lead Sponsor: Takeda

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2017-07-09
• Study First Submitted QC: 2017-07-09
• Study First Posted: 2017-07-11
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Results First Submitted: 2021-04-27
• Results First Submitted QC: 2021-04-27
• Results First Posted: 2021-05-19
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1304

Inclusion Criteria

• Participants with a history of gastric or duodenal ulcer

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vonoprazan 10 mg	Vonoprazan	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Had One or More Adverse Drug Reactions	Up to 12 months	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 administered drug.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Gastric Ulcers	Up to 12 months	The presence or absence of onset of gastric ulcers was reported. Reporting data was total percentage of participants with gastric ulcers.
Percentage of Participants With Duodenal Ulcers	Up to 12 months	The presence or absence of onset of duodenal ulcers was reported. Reporting data was total percentage of participants with duodenal ulcers.
Percentage of Participants With Duodenal Hemorrhagic Lesions	Up to 12 months	The presence or absence of onset of duodenal hemorrhagic lesions was reported. Reporting data was total percentage of participants with duodenal hemorrhagic lesions.
Percentage of Participants With Gastric Hemorrhagic Lesions	Up to 12 months	The presence or absence of onset of gastric hemorrhagic lesions was reported. Reporting data was total percentage of participants with gastric hemorrhagic lesions.

Trial Locations

Locations (1)

Takeda Selected Site; 🇯🇵 Tokyo, Japan