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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non Erosive Reflux Disease; Chronic Gastritis

Intervention: Esomeprazole (Drug); Esomeprazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Wenyu Guo, Study Director, Affiliation: AstraZeneca China MC
Prof. Yuan Yaozong, Principal Investigator, Affiliation: Shanghai Jiaotong University, School of Medicine, Affiliated of Ruijin Hospital

Summary

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.

Secondary outcome:

The Success Rate in Whole Study Duration.

Time to First Relapse.

Symptom Relief Rate in 2 Treatment Regimens.

Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.

Number of Patients With Unscheduled Hospital Visit(s)

Percentage of Patients Satisfaction

Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire

Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Research Site, Beijin, China

Research Site, Shanghai, China

Research Site, Guangzhou, Guangdong, China

Research Site, Wuhan, Hubei, China

Research Site, Nanjing, Jiangsu, China

Research Site, Jinan, Shandong, China

Research Site, Xian, Shanxi, China

Research Site, Hangzhou, Zhejiang, China

Additional Information

Starting date: April 2010
Last updated: September 26, 2012

Page last updated: August 23, 2015

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