Clinical trial NCT01119768: Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non Erosive Reflux Disease
Chronic Gastritis
Keywords: GI
Nexium
Phase IV
Co-diagnosed NERD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-05-10
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.
timeFrame: 24 weeks
Secondary outcomes:
measure: The Success Rate in Whole Study Duration.
timeFrame: 24 weeks after end of treatment
measure: Time to First Relapse.
timeFrame: From baseline to 24 weeks after end of treatment
measure: Symptom Relief Rate in 2 Treatment Regimens.
timeFrame: 8 weeks for arm 1, 2 weeks for arm 2
measure: Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.
timeFrame: 2 and 8 weeks
measure: Number of Patients With Unscheduled Hospital Visit(s)
timeFrame: from baseline to week 24 after end of treatment
measure: Percentage of Patients Satisfaction
timeFrame: 24 weeks after end of treatment
measure: Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire
timeFrame: 8 weeks
measure: Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Jinan
country: China
facility: Research Site
state: Shandong
city: Xian
country: China
facility: Research Site
state: Shanxi
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Beijin
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
Study officials:
affiliation: AstraZeneca China MC
name: Wenyu Guo
role: STUDY_DIRECTOR
affiliation: Shanghai Jiaotong University, School of Medicine, Affiliated of Ruijin Hospital
name: Prof. Yuan Yaozong
role: PRINCIPAL_INVESTIGATOR
References: