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Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin

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ClinicalTrials.gov Identifier: NCT01452763
Recruitment Status : Completed
First Posted : October 17, 2011
Last Update Posted : January 20, 2014
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE September 16, 2011
First Posted Date  ICMJE October 17, 2011
Last Update Posted Date January 20, 2014
Study Start Date  ICMJE October 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2011)
Recurrence rate of gastric or duodenal ulcer within 24 weeks [ Time Frame: 24 weeks ]
Mucosal defects with a white coating of 3 mm or larger will be determined as ulcers. Recurrence rate of gastric or duodenal ulcer within 24 weeks will be calculated for each treatment group.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2011)
  • Recurrence rate of gastric or duodenal ulcer within 12 weeks [ Time Frame: 12 weeks ]
  • Gastric mucosal injury [ Time Frame: 24 Weeks ]
  • Duodenal mucosal injury [ Time Frame: 24 weeks ]
  • Occurrence rate of hemorrhagic lesion in stomach or duodenum [ Time Frame: 24 weeks ]
  • Time to recurrence of gastric or duodenal ulcer [ Time Frame: 24 weeks ]
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 and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-blind, AG-1749-controlled, Parallel-group, Comparison Study to Evaluate the Efficacy and Safety of TAK-438 (10 mg or 20 mg, Orally, Once Daily) for the Prevention of Recurrent Gastric or Duodenal Ulcers During Long-term Therapy of Low-dose Aspirin
Brief Summary The purpose of this study is to evaluate the efficacy of TAK-438, once daily (QD) compared to AG-1749 (Lansoprazole) in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.
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: Prevention
Condition  ICMJE
  • Gastric Ulcers
  • Duodenal Ulcers
Intervention  ICMJE
  • Drug: TAK-438
    TAK-438 10 mg tablets, orally, once daily for up to 24 weeks.
  • Drug: Placebo
    Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
  • Drug: TAK-438
    TAK-438 20 mg tablets, orally, once daily for up to 24 weeks.
  • Drug: Lansoprazole
    Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.
    Other Name: AG-1749
  • Drug: Placebo
    TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks.
Study Arms  ICMJE
  • Experimental: TAK-438 10 mg QD
    Interventions:
    • Drug: TAK-438
    • Drug: Placebo
  • Experimental: TAK-438 20 mg QD
    Interventions:
    • Drug: TAK-438
    • Drug: Placebo
  • Active Comparator: Lansoprazole 15 mg QD
    Interventions:
    • Drug: Lansoprazole
    • Drug: Placebo
Publications * Kawai T, Oda K, Funao N, Nishimura A, Matsumoto Y, Mizokami Y, Ashida K, Sugano K. Vonoprazan prevents low-dose aspirin-associated ulcer recurrence: randomised phase 3 study. Gut. 2018 Jun;67(6):1033-1041. doi: 10.1136/gutjnl-2017-314852. Epub 2017 Dec 1.

*   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: January 13, 2014)
621
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2011)
630
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participants who require continuous low-dose aspirin therapy during the treatment period with the study drug
  2. Participants who have a history of ulcer in stomach or duodenum, endoscopically confirmed
  3. Outpatient (including inpatient for examinations)

Exclusion Criteria:

  1. Participants scheduled to change the type and dosage regimen of low-dose aspirin
  2. Participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed
  3. Participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology
  4. Participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery
  5. Participants with a previous or current history of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
  6. Participants with a previous or current history of aspirin-induced asthma
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 NCT01452763
Other Study ID Numbers  ICMJE TAK-438/CCT-302
U1111-1123-8746 ( Registry Identifier: WHO (UTN) )
JapicCTI-111610 ( 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 January 2014

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