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

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

Tracking Information

• First Submitted Date: September 16, 2011
• First Posted Date: October 17, 2011
• Last Update Posted Date: January 20, 2014
• Study Start Date: October 2011
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Gastric Ulcers
• Duodenal Ulcers

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 13, 2014): 621
• Original Estimated Enrollment (submitted: October 14, 2011): 630
• Actual Study Completion Date: April 2013
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT01452763
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Takeda
• Original Responsible Party: Same as current
• Current Study Sponsor: Takeda
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Senior Manager; Takeda

• PRS Account: Takeda
• Verification Date: January 2014