Skip to main content
OpenTrials
Completed

NCT Number: NCT03219723

Drug Use Surveillance of Takecab for "Supplement to Helicobacter Pylori Eradication"

The purpose of this study is to evaluate the safety and efficacy on participants receiving first-line eradication and second-line eradication including vonoprazan (Takecab) tablets (triple therapy) in the routine clinical setting.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Digestive System Diseases Duodenal Diseases Duodenal Ulcer Gastrointestinal Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Stomach Diseases Thrombocytopenia Thrombotic Microangiopathies

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 (Takecab). Vonoprazan is being tested to treat people who have gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, stomach following endoscopic treatment of early gastric cancer, or H. pylori gastritis. This study will look at the presence or absence of new concerns regarding the safety of triple therapy with Vonoprazan tablets, amoxicillin, and clarithromycin (first-line eradication) and triple therapy with Vonoprazan tablets, amoxicillin, and metronidazole (second-line eradication) for supplemental Helicobacter pylori (H. pylori) eradication in the routine clinical setting. The study will enroll approximately 500 patients.

First-line eradication

  • Vonoprazan 20 mg / Proton pump inhibitor
  • Amoxicillin hydrate 750 mg
  • Clarithromycin 200 mg

If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful.

Second-line eradication

  • Vonoprazan 20 mg
  • Amoxicillin hydrate 750 mg
  • metronidazole 250 mg

This multi-center trial 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 receiving H. pylori eradication treatment for the first time
  • Participants for whom H. pylori eradication with Takecab tablets or proton pump inhibitor + amoxicillin + clarithromycin was found unsuccessful and who will receive eradication treatment with amoxicillin and metronidazole

Exclusion criteria

  • Participants with previous history of hypersensitivity to ingredients in Takecab tablets
  • Participants taking atazanavir sulfate or rilpivirine hydrochloride

Treatment and study plan

Vonoprazan

Drug

Vonoprazan tablets

Other names: Takecab tablets, TAK-438

Amoxicillin hydrate

Drug

Amoxicillin hydrate (potency)

Clarithromycin

Drug

Clarithromycin (potency)

Metronidazole

Drug

Metronidazole

Primary outcomes

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

    Time frame: Up to 7 days and 2 months

    Adverse drug reaction refers to adverse events related to administered drug. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).

Secondary outcomes

  1. H. Pylori Eradication Rate

    Time frame: 7 days + 2 months

    In participants who were determined as achieving H. pylori eradication, the percentage of participants negative for H. pylori (eradication rates) was tabulated by first-line eradication and second-line eradication. Timeframe was defined as duration of triple therapy (7 days) and up to the time of determination of H. pylori eradication after triple therapy (approximately 2 months as maximum duration).

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Drug Use Surveillance of Takecab Tablets "Supplement to Helicobacter Pylori Eradication"

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 17, 2017
Registry last updated
Mar 22, 2019

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.