Skip to content

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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221947
Enrollment
Unknown
Registered
2012-10-24
Start date
2012-10-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Reflux Esophagitis

Interventions

investigational material(s) Generic name etc : Esomeprazole (D961H) INN of investigational material : Esomeprazole Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Provision of informed consent prior to any study specific procedures. -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. -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

Exclusion criteria

Exclusion criteria: -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 -Gastric or duodenal ulcer verified by Endoscopy within 12 weeks before randomisation. -Previous esophageal, gastric or duodenal surgery except simple closure of perforated ulcer, simple endoscopic treatment with simple operation etc -Current or historical evidence (within 12 weeks prior to randomisation ) of the diseases/conditions as judged to interfere with the evaluation of the study.

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026