Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population

AstraZeneca270 enrolled

Overview

The purpose of this study is to study safety and efficacy of omeprazole standard treatment in a Japanese non-erosive reflux disease population.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

270

Conditions

Non-erosive Reflux Disease

Interventions

OmeprazoleDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who identified their predominant symptom as heartburn and were classifiend as Grande M or N according to Hoshihara's modofied version of Los Angeles Classification at esophagogastroduodenoscopy. Exclusion Criteria: * Patients with any ongoing gastrointestinal bleeding at the time of esopgahogastroduodenoscopy, patients with any history of erosive esophagitis or any other major diseases or concommittant drugs likely to interfere with the evaluation of this study

Locations (26)

Unnamed facility

Asa, Japan

Unnamed facility

Beppu, Japan

Unnamed facility

Chiyoda City, Japan

Outcomes

Primary Outcomes

To determine the efficacy of omeoprazole 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.

Data from ClinicalTrials.gov

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