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Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients

NCT ID: NCT01119768

Last Updated: 2012-09-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

305 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-06-30

Brief Summary

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To compare the symptom control rate between 8 weeks esomeprazole treatment regimen group and 2 weeks esomeprazole treatment regimen group in co-diagnosed NERD and chronic gastritis patients, as evaluated by GerdQ after 24 weeks maintenance treatment/follow up.

Detailed Description

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A multicenter, randomized, open-label Phase IV study exploring symptom control rate in co-diagnosed NERD and chronic gastritis patients treated with 8 weeks esomeprazole treatment regimen and 2 weeks esomeprazole treatment regimen.

Conditions

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Non Erosive Reflux Disease Chronic Gastritis

Keywords

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GI Nexium Phase IV Co-diagnosed NERD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Esomeprazole 8 weeks treatment

20 mg q.d. (quaque die) once a day dosing for 8 weeks

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment

Esomeprazole 2 Weeks Treatment

20 mg q.d. (quaque die) once a day dosing for 2 weeks

Group Type ACTIVE_COMPARATOR

Esomeprazole

Intervention Type DRUG

20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up

Interventions

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Esomeprazole

20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment

Intervention Type DRUG

Esomeprazole

20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Heartburn and/or regurgitation symptoms last for at least 3 months
* Endoscopic diagnosed as chronic gastritis (non-atrophic, and mild atrophic gastritis) within 2 weeks prior to randomization GerdQ score =8

Exclusion Criteria

* Endoscopic visible reflux esophagitis, esophageal varices, Barrett's esophagus, malignancy or peptic ulcer Patients with Hp positive result and are eager to take Hp eradication therapy will be excluded
* If Hp positive, patients could take Hp eradication therapy after the study completion Previous PPI or H2RA therapy in the last 2 weeks before enrollment
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wenyu Guo

Role: STUDY_DIRECTOR

AstraZeneca China MC

Prof. Yuan Yaozong

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiaotong University, School of Medicine, Affiliated of Ruijin Hospital

Locations

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Research Site

Guangzhou, Guangdong, China

Site Status

Research Site

Wuhan, Hubei, China

Site Status

Research Site

Nanjing, Jiangsu, China

Site Status

Research Site

Jinan, Shandong, China

Site Status

Research Site

Xian, Shanxi, China

Site Status

Research Site

Hangzhou, Zhejiang, China

Site Status

Research Site

Beijin, , China

Site Status

Research Site

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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D9612L00127

Identifier Type: -

Identifier Source: org_study_id