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

H. Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505127
• Other study ID #: TAK-438/CCT-401
• Secondary ID: U1111-1126-5073J
• Status: Completed
• Phase: Phase 3
• First received: December 30, 2011
• Last updated: November 2, 2013
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: November 2013
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• H. Pylori Infection
• Helicobacter Infections

Intervention

Drug:
• TAK-438

• Lansoprazole

• Amoxicillin

• Clarithromycin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H. pylori eradication rate 4 weeks after completion of first-line therapy	The participants are judged to be H. pylori-negative or H. pylori-positive based on the 13C-Urea Breath Test.	4-weeks post-dose (first-line therapy)	No
Secondary	H. pylori eradication rate 4 weeks after completion of second-line therapy		4-weeks post-dose (second-line therapy)	No