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Completed

NCT Number: 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"

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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Key information

Conditions

A History of 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 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.

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 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

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

    Time frame: 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.

  2. Percentage of Participants With Duodenal Ulcers

    Time frame: 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.

  3. Percentage of Participants With Gastric Hemorrhagic Lesions

    Time frame: 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.

  4. Percentage of Participants With Duodenal Hemorrhagic Lesions

    Time frame: 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.

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 Non-steroidal Anti-inflammatory Drugs: Long-term Use"

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 11, 2017
Registry last updated
Jun 7, 2023

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.

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