Clinical trial NCT03214198: 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"
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"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: A History of Gastric or Duodenal Ulcers
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-07-11
Enrollment: 1304
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of participants with a historical diagnosis of gastric or duodenal ulcers and during NSAIDs administration in the routine medical care.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Who Had One or More Adverse Drug Reactions
timeFrame: Up to 12 months
Secondary outcomes:
measure: Percentage of Participants With Gastric Ulcers
timeFrame: Up to 12 months
measure: Percentage of Participants With Duodenal Ulcers
timeFrame: Up to 12 months
measure: Percentage of Participants With Gastric Hemorrhagic Lesions
timeFrame: Up to 12 months
measure: Percentage of Participants With Duodenal Hemorrhagic Lesions
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Kawai T, Suzuki C, Honda Y, Fernandez JL. Long-term safety and effectiveness of vonoprazan for prevention of gastric and duodenal ulcer recurrence in patients on nonsteroidal anti-inflammatory drugs in Japan: a 12-month post-marketing surveillance study. Expert Opin Drug Saf. 2023 Jan-Jun;22(5):425-431. doi: 10.1080/14740338.2023.2136163. Epub 2022 Oct 20.