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

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT01505127
Collaborator
(none)
650
Enrollment
35
Locations
2
Arms
17
Duration (Months)
18.6
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Jan 1, 2012
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

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 Names:
  • AG-1749

    • Drug: Amoxicillin

    Drug: Clarithromycin

    Outcome Measures

    Primary Outcome Measures

    1. H. pylori eradication rate 4 weeks after completion of first-line therapy [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 [4-weeks post-dose (second-line therapy)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    1. 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.

    1. Participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (ex, resection of upper gastrointestinal tract, vagotomy, etc)

    2. Participants who cannot be treated with medicinal treatment (ex, perforation, pyloric stenosis or large hemorrhage, etc)

    3. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders

    4. Participants with hepatic or renal impairment receiving treatment with colchicines

    5. Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients), PPIs, penicillin antibiotics, macrolide antibiotics, or antitrichomonal agents

    6. Participants with infectious mononucleosis

    7. Participants with an organic disease of the brain or spinal cord

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abiko-shi Chiba Japan
    2 Kashiwa-shi Chiba Japan
    3 Fukui-shi Fukui Japan
    4 Fukuoka-shi Fukuoka Japan
    5 Ishikari-shi Hokkaido Japan
    6 Sapporo-shi Hokkaido Japan
    7 Kobe-shi Hyogo Japan
    8 Nishinomiya-shi Hyogo Japan
    9 Marugame-shi Kagawa Japan
    10 Takamatsu-shi Kagawa Japan
    11 Kagoshima-shi Kagoshima Japan
    12 Ebina-shi Kanagawa Japan
    13 Yokohama-shi Kanagawa Japan
    14 Yatsushiro-shi Kumamoto Japan
    15 Kyoto-shi Kyoto Japan
    16 Oita-shi Oita Japan
    17 Hirakata-shi Osaka Japan
    18 Osaka-shi Osaka Japan
    19 Sakai-shi Osaka Japan
    20 Suita-shi Osaka Japan
    21 Takatsuki-shi Osaka Japan
    22 Toyonaka-shi Osaka Japan
    23 Saga-shi Saga Japan
    24 Kumagaya-shi Saitama Japan
    25 Tokorozawa-shi Saitama Japan
    26 Shizuoka-shi Shizuoka Japan
    27 Adachi-ku Tokyo Japan
    28 Chiyoda-ku Tokyo Japan
    29 Hachioji-shi Tokyo Japan
    30 Kokubunji-shi Tokyo Japan
    31 Nishi-tokyo-shi Tokyo Japan
    32 Oota-ku Tokyo Japan
    33 Ota-ku Tokyo Japan
    34 Setagaya-ku Tokyo Japan
    35 Shibuya-ku Tokyo Japan

    Sponsors and Collaborators

    • Takeda

    Investigators

    • Study Director: Senior Manager, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT01505127
    Other Study ID Numbers:
    • TAK-438/CCT-401
    • U1111-1126-5073
    • JapicCTI-111722
    First Posted:
    Jan 6, 2012
    Last Update Posted:
    Nov 5, 2013
    Last Verified:
    Nov 1, 2013
    Keywords provided by Takeda
    Drug Therapy
    Additional relevant MeSH terms:
    Amoxicillin
    Clarithromycin
    Lansoprazole
    Dexlansoprazole

    Study Results

    No Results Posted as of Nov 5, 2013