MedTrace Logo

Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)

NCT01669811 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1398

Last updated 2015-08-27

Study results available
· View outcomes & findings →

Summary

This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of esomeprazole magnesium salt) with refractory reflux esophagitis after 8 weeks of standard Proton-pump inhibitor (PPI) therapy by assessment of presence/absence of inflammation (esophagitis) at Week 8 according to the Los Angeles (LA) classification

Conditions

  • Refractory Reflux Esophagitis

Interventions

DRUG

Esomeprazole (D961H) twice daily

One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening

DRUG

Esomeprazole (D961H) once daily

One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and one corresponding placebo capsule in the evening

Sponsors & Collaborators

Principal Investigators

  • Tore Lind, MSD · AstraZeneca, Moelndal, Sweden

  • Lan Chen · AstraZeneca, Osaka, Japan

  • Yoshikazu Kinoshita, PROFESSOR OF MEDICINE · Dept of Gastroenterology and Hepatology, Shimane, Japan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-05-31
Completion
2014-05-31

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 NCT01669811 on ClinicalTrials.gov