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Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer

NCT01452724 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2013-08-20

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy of TAK-438, once daily (QD), compared to lansoprazole in patients with duodenal ulcer.

Conditions

  • Duodenal Ulcer

Interventions

DRUG

TAK-438

TAK-438 20 mg, tablets, orally, once daily for up to 6 weeks.

DRUG

Placebo

Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.

DRUG

Lansoprazole

Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks.

DRUG

Placebo

TAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks.

Sponsors & Collaborators

Principal Investigators

  • Senior Manager · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-02-28
Completion
2013-02-28

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 NCT01452724 on ClinicalTrials.gov