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

NCT01505127 | Completed Phase 3

• 3 other identifiers: TAK-438/CCT-401U1111-1126-5073JapicCTI-111722
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 35

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.

Conditions

H. Pylori Infection

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• H. pylori eradication rate 4 weeks after completion of second-line therapy

  4-weeks post-dose (second-line therapy)

Study Arms (2)

TAK-438 20 mg BID

EXPERIMENTAL

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

Lansoprazole 30 mg BID

EXPERIMENTAL

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; Drug: Amoxicillin; Drug: Clarithromycin

Interventions

TAK-438 DRUG

TAK-438 20 mg BID

Lansoprazole DRUG

Also known as: AG-1749

Lansoprazole 30 mg BID

Amoxicillin DRUG

Lansoprazole 30 mg BID; TAK-438 20 mg BID

Clarithromycin DRUG

Lansoprazole 30 mg BID; TAK-438 20 mg BID

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be H. pylori-positive patients at baseline (Visit 1)
• 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)

You may not qualify if:

• Participants who have received H.pylori eradication treatment
• 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

Sponsors & Collaborators

• Takeda: lead

Study Sites (35)

Unknown Facility

Abiko-shi, Chiba, Japan

Location

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Kashiwa-shi, Chiba, Japan

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Fukui-shi, Fukui, Japan

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Fukuoka, Fukuoka, Japan

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Ishikari-shi, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Kobe, Hyōgo, Japan

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Nishinomiya-shi, Hyōgo, Japan

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Marugame-shi, Kagawa-ken, Japan

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Takamatsu, Kagawa-ken, Japan

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Kagoshima, Kagoshima-ken, Japan

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Ebina-shi, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yatsushiro-shi, Kumamoto, Japan

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Kyoto, Kyoto, Japan

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Ōita, Oita Prefecture, Japan

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Hirakata-shi, Osaka, Japan

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Osaka, Osaka, Japan

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Sakai-shi, Osaka, Japan

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Suita-shi, Osaka, Japan

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Takatsuki-shi, Osaka, Japan

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Toyonaka-shi, Osaka, Japan

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Saga, Saga-ken, Japan

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Kumagaya-shi, Saitama, Japan

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Tokorozawa-shi, Saitama, Japan

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Shizuoka, Shizuoka, Japan

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Adachi-ku, Tokyo, Japan

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Chiyoda-ku, Tokyo, Japan

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Hachioji-shi, Tokyo, Japan

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Kokubunji-shi, Tokyo, Japan

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Nishi-Tokyo-shi, Tokyo, Japan

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Oota-ku, Tokyo, Japan

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Ōta-ku, Tokyo, Japan

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Unknown Facility

Setagaya-ku, Tokyo, Japan

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Unknown Facility

Shibuya-ku, Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 26935876 DERIVED

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Lansoprazole; Amoxicillin; Clarithromycin

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Senior Manager

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2011
• First Posted: January 6, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 5, 2013

Record last verified: 2013-11

Locations

JP (35)