Skip to main content
OpenTrials
Completed

NCT Number: NCT03214094

Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"

The purpose of this survey is to investigate the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric or Duodenal Ulcers Digestive System Diseases Duodenal Diseases Duodenal Ulcer Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda Selected Site

Tokyo, Japan

About this study

The drug being tested in this survey is called vonoprazan. Vonoprazan is being tested to treat people who have gastric or duodenal ulcers.

This survey will look at the safety and effectiveness of long-term administration of vonoprazan tablets for up to 12 months in the routine clinical setting in patients receiving low-dose aspirin.

The survey will enroll approximately 1,000 participants.

  • Vonoprazan 10 mg

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 hemorrhage at initiation vonoprazan therapy
  • Participants with a history of hypersensitivity to any ingredients in vonoprazan Tablets
  • Participants receiving atazanavir sulfate or rilpivirine hydrochloride

Treatment and study plan

Vonoprazan

Drug

Vonoprazan tablets

Other names: Takecab tablets, TAK-438

Primary outcomes

  1. Percentage of Participants Who Had One or More Adverse Drug Reactions

    Time frame: 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 outcomes

  1. Percentage of Participants With Gastric Ulcers After the Start of Administration of Vonoprazan Tablets

    Time frame: Up to 12 months

    Reported data were percentage of participants who experienced an onset of gastric ulcers after the start of administration of vonoprazan tablets.

  2. Percentage of Participants With Duodenal Ulcers After the Start of Administration of Vonoprazan Tablets

    Time frame: Up to 12 months

    Reported data were percentage of participants who experienced an onset of duodenal ulcers after the start of administration of vonoprazan tablets.

  3. Percentage of Participants With Hemorrhagic Lesions on Stomach After the Start of Administration of Vonoprazan Tablets

    Time frame: Up to 12 months

    Reported data were percentage of participants who had hemorrhagic lesions on stomach after the start of administration of vonoprazan tablets.

  4. Percentage of Participants With Hemorrhagic Lesions on Duodenum After the Start of Administration of Vonoprazan Tablets

    Time frame: Up to 12 months

    Reported data were percentage of participants who had hemorrhagic lesions on duodenum after the start of administration of vonoprazan tablets.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Special Drug Use Surveillance of Takecab Tablets for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin: Long-term Use"

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2017
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.