Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori
Information source: Takeda
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: H. Pylori Infection
Intervention: TAK-438 (Drug); Lansoprazole (Drug); Amoxicillin (Drug); Clarithromycin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Takeda Official(s) and/or principal investigator(s): Senior Manager, Study Director, Affiliation: Takeda
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: H. pylori eradication rate 4 weeks after completion of first-line therapy
Secondary outcome: H. pylori eradication rate 4 weeks after completion of second-line therapy
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 and Contacts
Abiko-shi, Chiba, Japan
Kashiwa-shi, Chiba, Japan
Fukui-shi, Fukui, Japan
Fukuoka-shi, Fukuoka, Japan
Ishikari-shi, Hokkaido, Japan
Sapporo-shi, Hokkaido, Japan
Kobe-shi, Hyogo, Japan
Nishinomiya-shi, Hyogo, Japan
Marugame-shi, Kagawa, Japan
Takamatsu-shi, Kagawa, Japan
Kagoshima-shi, Kagoshima, Japan
Ebina-shi, Kanagawa, Japan
Yokohama-shi, Kanagawa, Japan
Yatsushiro-shi, Kumamoto, Japan
Kyoto-shi, Kyoto, Japan
Oita-shi, Oita, Japan
Hirakata-shi, Osaka, Japan
Osaka-shi, Osaka, Japan
Sakai-shi, Osaka, Japan
Suita-shi, Osaka, Japan
Takatsuki-shi, Osaka, Japan
Toyonaka-shi, Osaka, Japan
Saga-shi, Saga, Japan
Kumagaya-shi, Saitama, Japan
Tokorozawa-shi, Saitama, Japan
Shizuoka-shi, Shizuoka, Japan
Adachi-ku, Tokyo, Japan
Chiyoda-ku, Tokyo, Japan
Hachioji-shi, Tokyo, Japan
Kokubunji-shi, Tokyo, Japan
Nishi-tokyo-shi, Tokyo, Japan
Oota-ku, Tokyo, Japan
Ota-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Shibuya-ku, Tokyo, Japan
Additional Information
Starting date: January 2012
Last updated: November 2, 2013
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