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

Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219723
• Other study ID #: Vonoprazan-5002
• Secondary ID: JapicCTI-153003
• Status: Completed
• Start date: September 1, 2015
• Est. completion date: April 30, 2017

Study information

• Verified date: December 2018
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Duodenal Ulcer
• Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other
• Gastritis
• Lymphoma, B-Cell, Marginal Zone
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Stomach Ulcer

Intervention

Drug:
• Vonoprazan
Vonoprazan tablets
• Amoxicillin hydrate
Amoxicillin hydrate (potency)
• Clarithromycin
Clarithromycin (potency)
• Metronidazole
Metronidazole

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	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).	Up to 7 days and 2 months
Secondary	H. Pylori Eradication Rate	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).	7 days + 2 months