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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

NCT01452763 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 621

Last updated 2014-01-20

No results posted yet for this study

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.

Conditions

  • Gastric Ulcers
  • Duodenal Ulcers

Interventions

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

Placebo

Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.

DRUG

Lansoprazole

Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.

DRUG

Placebo

TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks.

Sponsors & Collaborators

Principal Investigators

  • Senior Manager · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01452763 on ClinicalTrials.gov