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A Double-Blind, Randomised, Parallel-Group, Multicentre, Phase III Study to Compare the Efficacy of Omeprazole 20mg and 10mg Od for the Four-Week Treatment of Non-Erosive Reflux Disease (NERD) with That of Placebo Od and to Investigate Safety

A Double-Blind, Randomised, Parallel-Group, Multicentre, Phase III Study to Compare the Efficacy of Omeprazole 20mg and 10mg Od for the Four-Week Treatment of Non-Erosive Reflux Disease (NERD) with That of Placebo Od and to Investigate Safety

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220395
Enrollment
Unknown
Registered
2007-05-24
Start date
2007-05-24
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

Non-Erosive Reflux Disease

Interventions

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

Sponsors

AstraZeneca/Mitsubishi Tanabe Pharma Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Ages Eligible for Study: 20 Years and above Genders Eligible for Study: Both Criteria Inclusion Criteria: -Patients who identified their predominant symptom as heartburn and were classified as Grade M or N according to Hoshihara's modified version of Los Angeles Classification at esophagogastroduodenoscopy. Exclusion Criteria: -Patients with any ongoing gastrointestinal bleeding at the time of esophagogastroduodenoscopy, patients with any history of erosive esophagitis or any other major diseases or concomitant drugs likely to interfere with the evaluation of this study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Efficacy Primary Outcomes: To determine the efficacy of omeprazole 20mg and omeprazole 10mg by assessment of complete resolution rate of heartburn during the fourth week of treatment. Secondary Outcomes: Complete resolution of heartburn during the first and second week of treatment, assessment of sufficient relief rates of heartburn, assessment of nocturnal heartburn, assessment of other GERD symptoms.—

Contacts

Public Contact; ;

AstraZeneca;Mitsubishi Tanabe Pharma Corporation

;;

Outcome results

None listed

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