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A Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Once Daily Oral Administration With Omeprazole 10 mg and D961H 10 mg Once Daily Oral Administration in Maintenance Treatment in Patients With Healed Reflux Esophagitis.

A Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Study to Compare the Efficacy and Safety of D961H 20 mg Once Daily Oral Administration With Omeprazole 10 mg and D961H 10 mg Once Daily Oral Administration in Maintenance Treatment in Patients With Healed Reflux Esophagitis.

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220625
Enrollment
Unknown
Registered
2008-10-20
Start date
2008-10-20
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

Reflux Esophagitis

Interventions

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

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Accepts Healthy Volunteers: No -Patients with healed Reflux Esophagitis verified by EGD(Esophagogastroduodenoscopy) in the preceding study (D961HC00002) -Patients with endoscopically verified healed Reflux Esophagitis by EGD receiving general treatment with PPI

Exclusion criteria

Exclusion criteria: -Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation. -Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation.

Design outcomes

Primary

MeasureTime frame
Presence/absence of recurrence of Reflux Esophagitis. [ Time Frame: throughout the treatment period ] [ Designated as safety issue: No ] Los Angeles classification—

Secondary

MeasureTime frame
Presence/absence of recurrence of Reflux Esophagitis. [ Time Frame: at Week 4 or before and Week 12 or before ] [ Designated as safety issue: No ] Los Angeles classification—

Outcome results

None listed

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