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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
305
20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment
20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up
Research Site
Guangzhou, Guangdong, China
Research Site
Wuhan, Hubei, China
Research Site
Nanjing, Jiangsu, China
Research Site
Jinan, Shandong, China
Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.
GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.
Time frame: 24 weeks
The Success Rate in Whole Study Duration.
Success is defined as patients with symptom relief after 8 weeks or 2 weeks esomeprazole treatment, and also get symptom controlled during maintenance treatment / follow-up period.
Time frame: 24 weeks after end of treatment
Time to First Relapse.
Time to first relapse is from the last dose during the treatment period to date of first time patient comes to the investigator due to symptom recure and need for treatment. Time to first relapse is actually the time when 50% of patients had relapse. Up to the end of study, there were less than 50% of the patients in arm esomeprazole 2 weeks group had relapse so was unable to compute this endpoint
Time frame: From baseline to 24 weeks after end of treatment
Symptom Relief Rate in 2 Treatment Regimens.
Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.
Time frame: 8 weeks for arm 1, 2 weeks for arm 2
Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.
Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.
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Research Site
Xian, Shanxi, China
Research Site
Hangzhou, Zhejiang, China
Research Site
Beijin, China
Research Site
Shanghai, China
Time frame: 2 and 8 weeks
Number of Patients With Unscheduled Hospital Visit(s)
Time frame: from baseline to week 24 after end of treatment
Percentage of Patients Satisfaction
Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2.
Time frame: 24 weeks after end of treatment
Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire
GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.
Time frame: 8 weeks
Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire
GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.
Time frame: 16 weeks