MedTrace Logo

Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis

NCT00770913 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 337

Last updated 2012-04-18

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.

Conditions

  • Refractory Reflux Esophagitis

Interventions

DRUG

E3810

20 mg taken orally, once a day for 8 weeks.

DRUG

E3810

10 mg, taken orally, twice a day for 8 weeks.

DRUG

E3810

20 mg taken orally, twice a day for 8 weeks.

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Tomoki Kubota · New Product Development Dept., Clinical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-11-30
Completion
2010-03-31

Countries

  • Japan

Study Locations

More Related Trials

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 NCT00770913 on ClinicalTrials.gov