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Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori

A Phase 3, Randomized, Double-Blind, Double Dummy, Multicenter, Parallel Group Comparison Study to Evaluate Efficacy and Safety of a Triple Therapy With TAK-438, Amoxicillin and Clarithromycin by Comparison With a Triple Therapy With AG-1749 (Lansoprazole), Amoxicillin and Clarithromycin for the First Line Eradication of H.Pylori

NCT01505127•Takeda

View on ClinicalTrials.gov

Summary

The purpose of this study is to confirm the efficacy of triple therapy with TAK-438, Amoxicillin and Clarithromycin, twice daily (BID) by demonstrating its non-inferiority to triple therapy with Lansoprazole, Amoxicillin and Clarithromycin in H. pylori-positive patients with scarred gastric or duodenal ulcers.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Participants must be H. pylori-positive patients at baseline (Visit 1)
•2. Participants must be endoscopically confirmed to have scarred gastric ulcer or duodenal ulcer at baseline (Visit 1).
•However, if a history of ulcers is confirmed by the medical interview or previous medical record, Participants whose gastric ulcer scar or duodenal ulcer scar has disappeared may be included in the study.
•3. Outpatient (including inpatient for examination)

Exclusion Criteria

•1. Participants who have received H.pylori eradication treatment
•2. Participants who have either acute upper gastrointestinal bleeding, gastric ulcer \[mucosal defect (with white coating including clot adherence) of 3 mm or larger in size\], duodenal ulcer \[mucosal defect (with white coating including clot adherence) of 3 mm or larger in size\], acute gastric mucosal lesion (AGML), or acute duodenal mucosal lesion (ADML) on endoscopic examination at baseline (Visit 1).
•However, participants with gastric erosion or duodenal erosion may be included in the study.
•3. Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (ex, resection of upper gastrointestinal tract, vagotomy, etc)
•4. Participants who cannot be treated with medicinal treatment (ex, perforation, pyloric stenosis or large hemorrhage, etc)
•5. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
•6. Participants with hepatic or renal impairment receiving treatment with colchicines
•7. Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients), PPIs, penicillin antibiotics, macrolide antibiotics, or antitrichomonal agents
•8. Participants with infectious mononucleosis
•9. Participants with an organic disease of the brain or spinal cord

Locations (35)

Abiko-shi, Chiba, Japan

Kashiwa-shi, Chiba, Japan

Fukui-shi, Fukui, Japan

Fukuoka, Fukuoka, Japan

Ishikari-shi, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Kobe, Hyōgo, Japan

Nishinomiya-shi, Hyōgo, Japan

Marugame-shi, Kagawa-ken, Japan

Takamatsu, Kagawa-ken, Japan

Key Dates

Start Date

January 1, 2012

Primary Completion Date

June 1, 2013

Completion Date

June 1, 2013

Last Updated

November 5, 2013

Enrollment

650

ACTUAL participants

Conditions

H. Pylori Infection

Interventions

TAK-438

DRUG

Lansoprazole

DRUG

Amoxicillin

DRUG

Clarithromycin

DRUG

Efficacy of Vonoprazan Based Dual and Triple Therapy for Patient With Helicobacter Pylori Infection

NCT07045688

H. Pylori Infection

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UNKNOWN

Early Detection and Screening Strategy of Gatric Cancer in Sichuan Province-A Prospective Cohort Study (WCH-GC-SIGES-01)

NCT03597672

Neoplasm, StomachH. Pylori Infection+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori

Inclusion Criteria

Exclusion Criteria

Efficacy of Vonoprazan Based Dual and Triple Therapy for Patient With Helicobacter Pylori Infection

Early Detection and Screening Strategy of Gatric Cancer in Sichuan Province-A Prospective Cohort Study (WCH-GC-SIGES-01)

The Efficacy of Sequential Therapy as Second Line Therapy for Refractory Helicobacter Pylori Infection - A Pilot Study

Establish Epidemiologic Data of H. Pylori Infection in Children and Adolescents-Using C13-UBT