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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Refractory Reflux Esophagitis

Treatments: Drug: Esomeprazole (D961H) twice daily; Drug: Esomeprazole (D961H) once daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT01669811

D961UC00002

Details and patient eligibility

About

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

Full description

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

Enrollment: 1,398 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Provision of informed consent prior to any study specific procedures.
2. 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.
3. 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.
4. Patients who are able to complete the Patient Diary

Exclusion criteria

1. Male or female aged less than 20 years at the time of informed consent.
2. Patients with current evidence of the gastrointestinal diseases/conditions such as esophageal stricture to interfere with the evaluation of the study etc
3. Gastric or duodenal ulcer verified by Endoscopy within 12 weeks before randomisation.
4. Previous esophageal, gastric or duodenal surgery except simple closure of perforated ulcer, simple endoscopic treatment with simple operation etc
5. Current or historical evidence (within 12 weeks prior to randomisation) of the diseases/conditions as judged to interfere with the evaluation of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,398 participants in 2 patient groups

D961H 20mg twice daily

Experimental group

Description:

Double-blinded

Treatment:

Drug: Esomeprazole (D961H) twice daily

D961H 20mg once daily

Active Comparator group

Description:

Double-blinded

Treatment:

Drug: Esomeprazole (D961H) once daily