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

Study Overview
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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.

Official Title
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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

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Esomeprazole


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Esomeprazole 8 weeks treatment<br>20 mg q.d. (quaque die) once a day dosing for 8 weeks | Drug: Esomeprazole<br>* 20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment<br>|
| Active Comparator: Esomeprazole 2 Weeks Treatment<br>20 mg q.d. (quaque die) once a day dosing for 2 weeks | Drug: Esomeprazole<br>* 20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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. | 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. | 2 and 8 weeks | 
| Number of Patients With Unscheduled Hospital Visit(s) |  | 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. | 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. | 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. | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GI, Nexium, Phase IV, Co-diagnosed NERD