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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

This study is currently recruiting participants.
Verified July 2012 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:
NCT01452763
First received: September 16, 2011
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastric Ulcers
Duodenal Ulcers
 Drug: TAK-438
Drug: Placebo
Drug: Lansoprazole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Recurrence rate of gastric or duodenal ulcer within 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Recurrence rate of gastric or duodenal ulcer within 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Gastric mucosal injury [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Duodenal mucosal injury [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Occurrence rate of hemorrhagic lesion in stomach or duodenum [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Time to recurrence of gastric or duodenal ulcer [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 630
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Arms Assigned Interventions
Experimental: TAK-438 10 mg QD 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.
Experimental: TAK-438 20 mg QD Drug: TAK-438
TAK-438 20 mg tablets, orally, once daily for up to 24 weeks.
Drug: Placebo
Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
Active Comparator: Lansoprazole 15 mg QD 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452763

Contacts
Contact: Takeda Study Registration Call Center 800-778-2860 medicalinformation@tpna.com

  Show 76 Study Locations
Sponsors and Collaborators
Takeda Pharmaceutical Company Limited
Investigators
Study Director: Senior Manager Takeda Pharmaceutical Company Limited
  More Information

No publications provided

Responsible Party: Takeda ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier: NCT01452763     History of Changes
Other Study ID Numbers: TAK-438/CCT-302, U1111-1123-8746, JapicCTI-111610
Study First Received: September 16, 2011
Last Updated: July 25, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Drug Therapy

Additional relevant MeSH terms:
Duodenal Ulcer
Stomach Ulcer
Ulcer
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
 Pathologic Processes
Lansoprazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013