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"

A History of Gastric or Duodenal Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03214198
• Other study ID #: Vonoprazan-5005
• Secondary ID: JapicCTI-163436
• Status: Completed
• Start date: September 1, 2016
• Est. completion date: April 30, 2020

Study information

• Verified date: June 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1304
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• A History of Gastric or Duodenal Ulcers
• Duodenal Ulcer
• Recurrence
• Ulcer

Intervention

Drug:
• Vonoprazan
Vonoprazan tablets

Locations

Country	Name	City	State
Japan	Takeda Selected Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Had One or More Adverse Drug Reactions	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.	Up to 12 months
Secondary	Percentage of Participants With Gastric Ulcers	The presence or absence of onset of gastric ulcers was reported. Reporting data was total percentage of participants with gastric ulcers.	Up to 12 months
Secondary	Percentage of Participants With Duodenal Ulcers	The presence or absence of onset of duodenal ulcers was reported. Reporting data was total percentage of participants with duodenal ulcers.	Up to 12 months
Secondary	Percentage of Participants With Gastric Hemorrhagic Lesions	The presence or absence of onset of gastric hemorrhagic lesions was reported. Reporting data was total percentage of participants with gastric hemorrhagic lesions.	Up to 12 months
Secondary	Percentage of Participants With Duodenal Hemorrhagic Lesions	The presence or absence of onset of duodenal hemorrhagic lesions was reported. Reporting data was total percentage of participants with duodenal hemorrhagic lesions.	Up to 12 months