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A Comparative Study on the Efficacy and Safety of E3810 in Patients With Non-erosive Gastroesophageal Reflux Disease

NCT00165646 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2011-07-18

Study results available
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Summary

To investigate the efficacy and safety of a 4-week treatment of 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)) in patients with non-erosive gastroesophageal reflux disease in a multicenter, randomized, double-blind, comparative study.

Conditions

  • Non-erosive Gastroesophageal Reflux Disease

Interventions

DRUG

E3810

E3810 5mg: once daily orally for 4 weeks

DRUG

E3810

E3810 10mg: once daily orally for 4 weeks

DRUG

Placebo

Placebo: once daily orally for 4 weeks

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Nobuyuki Sugisaki · Eisai Co., Ltd - Development Clinical Research Department. 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
2004-09-30
Primary Completion
2005-10-31
Completion
2005-10-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

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 NCT00165646 on ClinicalTrials.gov