MedTrace Logo

Long-Term Safety Study of TAK-438 in the Maintenance Treatment of Healed Erosive Esophagitis

NCT01452776 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 305

Last updated 2013-11-05

No results posted yet for this study

Summary

The purpose of this study is to determine the safety of long term use of TAK-438, once daily (QD), for the maintenance treatment of healed erosive esophagitis.

Conditions

  • Erosive Esophagitis

Interventions

DRUG

TAK-438

TAK-438 10 mg, tablets, orally, once daily for up to 52 weeks.

DRUG

TAK-438

TAK-438 20 mg, tablets, orally, once daily for up to 52 weeks.

Sponsors & Collaborators

Principal Investigators

  • Senior Manager · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

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 NCT01452776 on ClinicalTrials.gov