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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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Takeda

Status and phase

Completed
Phase 3

Conditions

Duodenal Ulcers
Gastric Ulcers

Treatments

Drug: Lansoprazole
Drug: TAK-438
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01452763
TAK-438/CCT-302
JapicCTI-111610 (Registry Identifier)
U1111-1123-8746 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

621 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

621 participants in 3 patient groups

TAK-438 10 mg QD
Experimental group
Treatment:
Drug: Placebo
Drug: TAK-438
Drug: Placebo
Drug: Placebo
Drug: TAK-438
TAK-438 20 mg QD
Experimental group
Treatment:
Drug: Placebo
Drug: TAK-438
Drug: Placebo
Drug: Placebo
Drug: TAK-438
Lansoprazole 15 mg QD
Active Comparator group
Treatment:
Drug: Placebo
Drug: Placebo
Drug: Placebo
Drug: Lansoprazole

Trial contacts and locations

76

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Data sourced from clinicaltrials.gov

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