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

Phase 3

Completed

• Conditions: H. Pylori Infection
• Interventions: Drug: TAK-438; Drug: Lansoprazole; Drug: Amoxicillin; Drug: Clarithromycin

• Registration Number: NCT01505127
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-30
• Study Start: 2012-01
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-02
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAK-438 20 mg BID	TAK-438	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
TAK-438 20 mg BID	Amoxicillin	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
TAK-438 20 mg BID	Clarithromycin	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
Lansoprazole 30 mg BID	Lansoprazole	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
Lansoprazole 30 mg BID	Amoxicillin	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
Lansoprazole 30 mg BID	Clarithromycin	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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