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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

Tracking Information
First Submitted Date  ICMJE December 30, 2011
First Posted Date  ICMJE January 6, 2012
Last Update Posted Date November 5, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2012)
H. pylori eradication rate 4 weeks after completion of second-line therapy [ Time Frame: 4-weeks post-dose (second-line therapy) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE H. Pylori Infection
Intervention  ICMJE
  • Drug: TAK-438
  • Drug: Lansoprazole
    Other Name: AG-1749
  • Drug: Amoxicillin
  • Drug: Clarithromycin
Study Arms  ICMJE
  • 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

    Interventions:
    • 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

    Interventions:
    • Drug: Lansoprazole
    • Drug: Amoxicillin
    • Drug: Clarithromycin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2013)
650
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2012)
440
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01505127
Other Study ID Numbers  ICMJE TAK-438/CCT-401
U1111-1126-5073 ( Registry Identifier: WHO )
JapicCTI-111722 ( Registry Identifier: JapicCTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Senior Manager Takeda
PRS Account Takeda
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP