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Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis

NCT01452698 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 409

Last updated 2012-11-09

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 erosive esophagitis of Grade A to D as defined by the LA classification grading system.

Conditions

  • Erosive Esophagitis

Interventions

DRUG

TAK-438

TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.

DRUG

Placebo

Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.

DRUG

Lansoprazole

Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks.

DRUG

Placebo

TAK-438 placebo-matching tablets, orally, once daily for up to 8 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

Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Japan

Study Locations

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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 NCT01452698 on ClinicalTrials.gov