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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01505127

Enrollment

650

Registered

2012-01-06

Start date

2012-01-31

Completion date

2013-06-30

Last updated

2013-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H. Pylori Infection

Keywords

Drug Therapy

Brief 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.

Interventions

DRUGTAK-438

DRUGLansoprazole

DRUGAmoxicillin

DRUGClarithromycin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
H. pylori eradication rate 4 weeks after completion of first-line therapy	4-weeks post-dose (first-line therapy)	The participants are judged to be H. pylori-negative or H. pylori-positive based on the 13C-Urea Breath Test.

Secondary

Measure	Time frame
H. pylori eradication rate 4 weeks after completion of second-line therapy	4-weeks post-dose (second-line therapy)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026