Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori
NCT ID: NCT01505127
Last Updated: 2013-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
650 participants
INTERVENTIONAL
2012-01-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
TAK-438
Amoxicillin
Clarithromycin
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
Lansoprazole
Amoxicillin
Clarithromycin
Interventions
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TAK-438
Lansoprazole
Amoxicillin
Clarithromycin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Manager
Role: STUDY_DIRECTOR
Takeda
Locations
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Abiko-shi, Chiba, Japan
Kashiwa-shi, Chiba, Japan
Fukui-shi, Fukui, Japan
Fukuoka, Fukuoka, Japan
Ishikari-shi, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Kobe, Hyōgo, Japan
Nishinomiya-shi, Hyōgo, Japan
Marugame-shi, Kagawa-ken, Japan
Takamatsu, Kagawa-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Ebina-shi, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Yatsushiro-shi, Kumamoto, Japan
Kyoto, Kyoto, Japan
Ōita, Oita Prefecture, Japan
Hirakata-shi, Osaka, Japan
Osaka, Osaka, Japan
Sakai-shi, Osaka, Japan
Suita-shi, Osaka, Japan
Takatsuki-shi, Osaka, Japan
Toyonaka-shi, Osaka, Japan
Saga, Saga-ken, Japan
Kumagaya-shi, Saitama, Japan
Tokorozawa-shi, Saitama, Japan
Shizuoka, 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
Ōta-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Shibuya-ku, Tokyo, Japan
Countries
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References
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Murakami K, Sakurai Y, Shiino M, Funao N, Nishimura A, Asaka M. Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: a phase III, randomised, double-blind study. Gut. 2016 Sep;65(9):1439-46. doi: 10.1136/gutjnl-2015-311304. Epub 2016 Mar 2.
Other Identifiers
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U1111-1126-5073
Identifier Type: REGISTRY
Identifier Source: secondary_id
JapicCTI-111722
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-438/CCT-401
Identifier Type: -
Identifier Source: org_study_id