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

Takeda

Status and phase: Completed; Phase 3

Conditions: H. Pylori Infection

Treatments: Drug: Clarithromycin; Drug: Lansoprazole; Drug: Amoxicillin; Drug: TAK-438

Study type: Interventional

Funder types: Industry

Identifiers

NCT01505127

JapicCTI-111722 (Registry Identifier)

TAK-438/CCT-401

U1111-1126-5073 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 650 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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650 participants in 2 patient groups

TAK-438 20 mg BID

Experimental group

Description:

TAK-438 20 mg, tablets, orally, twice daily for 1 week Lansoprazole placebo-matching capsules, orally, twice daily for 1 week Amoxicillin 750 mg, capsules, orally, twice daily for 1 week Clarithromycin 200 or 400 mg, tablets, orally, twice daily for 1 week

Treatment:

Drug: Clarithromycin

Drug: Amoxicillin

Drug: TAK-438

Lansoprazole 30 mg BID

Experimental group

Description:

TAK-438 placebo-matching tablets, orally, twice daily for 1 week Lansoprazole 30 mg, capsules, orally, twice daily for 1 week Amoxicillin 750 mg, capsules, orally, twice daily for 1 week Clarithromycin 200 or 400 mg, tablets, orally, twice daily for 1 week

Treatment:

Drug: Clarithromycin

Drug: Lansoprazole

Drug: Amoxicillin