Completed
A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Twice Daily Oral Administration and D961H 20 mg Once Daily Oral Administration in Patients With Refractory Reflux Esophagitis
What is being tested
Esomeprazole (D961H) twice daily
+ Esomeprazole (D961H) once daily
Drug
Who is being recruted
Digestive System Diseases+7
+ Duodenal Diseases
+ Esophageal Diseases
Over 20 Years
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: August 2012
Summary
Principal SponsorAstraZeneca
Last updated: August 27, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.A multicentre, randomised, double-blind, parallel-group, comparative study to compare the efficacy and safety of D961H 20 mg twice daily oral administration and D961H 20 mg once daily oral administration in patients with refractory reflux esophagitis
Principal SponsorAstraZeneca
Last updated: August 27, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
1398 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 20 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Digestive System DiseasesDuodenal DiseasesEsophageal DiseasesEsophagitisGastroenteritisGastrointestinal DiseasesIntestinal DiseasesPeptic UlcerStomach DiseasesEsophagitis, Peptic
Criteria
4 inclusion criteria required to participate
Patients must fulfill at least one of the following criteria such as (i) RE with LA grade C/D at Endoscopy on visit 1 and/or history of RE with LA grade C/D, (ii) RE was diagnosed more than 1 year before visit 1
Patients who are able to complete the Patient Diary
Patients with RE classified into LA classification Grade A, B, C or D by Endoscopy despite of at least 8-week treatment using standard doses of PPIs
Provision of informed consent prior to any study specific procedures
5 exclusion criteria prevent from participating
Current or historical evidence (within 12 weeks prior to randomisation) of the diseases/conditions as judged to interfere with the evaluation of the study
Gastric or duodenal ulcer verified by Endoscopy within 12 weeks before randomisation
Male or female aged less than 20 years at the time of informed consent
Patients with current evidence of the gastrointestinal diseases/conditions such as esophageal stricture to interfere with the evaluation of the study etc
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalDouble-blinded
Group II
Active ComparatorDouble-blinded
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 63 locations
Research Site
Adachi-ku, JapanResearch Site
Annaka-shi, JapanResearch Site
Asahikawa-shi, JapanCompleted63 Study Centers