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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01505127
First received: December 30, 2011
Last updated: November 2, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
H. Pylori Infection
Drug: TAK-438
Drug: Lansoprazole
Drug: Amoxicillin
Drug: Clarithromycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • H. pylori eradication rate 4 weeks after completion of first-line therapy [ Time Frame: 4-weeks post-dose (first-line therapy) ] [ Designated as safety issue: No ]
    The participants are judged to be H. pylori-negative or H. pylori-positive based on the 13C-Urea Breath Test.


Secondary Outcome Measures:
  • H. pylori eradication rate 4 weeks after completion of second-line therapy [ Time Frame: 4-weeks post-dose (second-line therapy) ] [ Designated as safety issue: No ]

Enrollment: 650
Study Start Date: January 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505127

Locations
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
Study Director: Senior Manager Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01505127     History of Changes
Other Study ID Numbers: TAK-438/CCT-401, U1111-1126-5073, JapicCTI-111722
Study First Received: December 30, 2011
Last Updated: November 2, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Clarithromycin
Lansoprazole
Dexlansoprazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors

ClinicalTrials.gov processed this record on October 16, 2014