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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01505127
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : November 5, 2013
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
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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.

Condition or disease Intervention/treatment Phase
H. Pylori Infection Drug: TAK-438 Drug: Lansoprazole Drug: Amoxicillin Drug: Clarithromycin Phase 3

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. H. pylori eradication rate 4 weeks after completion of second-line therapy [ Time Frame: 4-weeks post-dose (second-line therapy) ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Senior Manager Takeda
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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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