Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori
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ClinicalTrials.gov Identifier: NCT01505127 |
Recruitment Status :
Completed
First Posted : January 6, 2012
Last Update Posted : November 5, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
H. Pylori Infection | Drug: TAK-438 Drug: Lansoprazole Drug: Amoxicillin Drug: Clarithromycin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 650 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | January 2012 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: TAK-438 20 mg BID
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 |
Drug: TAK-438 Drug: Amoxicillin Drug: Clarithromycin |
Experimental: Lansoprazole 30 mg BID
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 |
Drug: Lansoprazole
Other Name: AG-1749 Drug: Amoxicillin Drug: Clarithromycin |
- H. pylori eradication rate 4 weeks after completion of first-line therapy [ Time Frame: 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.
- H. pylori eradication rate 4 weeks after completion of second-line therapy [ Time Frame: 4-weeks post-dose (second-line therapy) ]

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants must be H. pylori-positive patients at baseline (Visit 1)
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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.
- Outpatient (including inpatient for examination)
Exclusion Criteria:
- Participants who have received H.pylori eradication treatment
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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.
- Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (ex, resection of upper gastrointestinal tract, vagotomy, etc)
- Participants who cannot be treated with medicinal treatment (ex, perforation, pyloric stenosis or large hemorrhage, etc)
- Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
- Participants with hepatic or renal impairment receiving treatment with colchicines
- Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients), PPIs, penicillin antibiotics, macrolide antibiotics, or antitrichomonal agents
- Participants with infectious mononucleosis
- Participants with an organic disease of the brain or spinal cord

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505127
Japan | |
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 |
Study Director: | Senior Manager | Takeda |
Responsible Party: | Takeda |
ClinicalTrials.gov Identifier: | NCT01505127 |
Other Study ID Numbers: |
TAK-438/CCT-401 U1111-1126-5073 ( Registry Identifier: WHO ) JapicCTI-111722 ( Registry Identifier: JapicCTI ) |
First Posted: | January 6, 2012 Key Record Dates |
Last Update Posted: | November 5, 2013 |
Last Verified: | November 2013 |
Drug Therapy |
Amoxicillin Clarithromycin Lansoprazole Dexlansoprazole Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors |