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Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)

NCT01456260 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2014-05-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of TAK-438, once daily (QD), during long-term concomitant non-steroidal anti-inflammatory drug (NSAID) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of NSAID.

Conditions

  • Gastric Ulcers
  • Duodenal Ulcers

Interventions

DRUG

TAK-438

TAK-438 10 mg tablets, orally, once daily for 28-80 weeks.

DRUG

Placebo

Lansoprazole placebo matching capsules, orally, once daily for 28-80 weeks.

DRUG

TAK-438

TAK-438 20 mg tablets, orally, once daily for 28-80 weeks.

DRUG

Placebo

Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.

DRUG

Lansoprazole

Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.

DRUG

Placebo

TAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks.

Sponsors & Collaborators

Principal Investigators

  • Senior Manager · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Completion
2013-12-31

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 NCT01456260 on ClinicalTrials.gov