Back to resultsEsomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients
Primary Purpose
Non Erosive Reflux Disease, Chronic Gastritis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Esomeprazole
Esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Non Erosive Reflux Disease focused on measuring GI, Nexium, Phase IV, Co-diagnosed NERD
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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Esomeprazole 8 weeks treatment
Esomeprazole 2 Weeks Treatment
Arm Description
20 mg q.d. (quaque die) once a day dosing for 8 weeks
20 mg q.d. (quaque die) once a day dosing for 2 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 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
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.
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.
Number of Patients With Unscheduled Hospital Visit(s)
Percentage of Patients Satisfaction
Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01119768
Brief Title
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
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Erosive Reflux Disease, Chronic Gastritis
Keywords
GI, Nexium, Phase IV, Co-diagnosed NERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
305 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esomeprazole 8 weeks treatment
Arm Type
Active Comparator
Arm Description
20 mg q.d. (quaque die) once a day dosing for 8 weeks
Arm Title
Esomeprazole 2 Weeks Treatment
Arm Type
Active Comparator
Arm Description
20 mg q.d. (quaque die) once a day dosing for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up
Primary Outcome Measure Information:
Title
Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.
Description
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
Secondary Outcome Measure Information:
Title
The Success Rate in Whole Study Duration.
Description
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
Title
Time to First Relapse.
Description
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
Title
Symptom Relief Rate in 2 Treatment Regimens.
Description
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
Title
Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.
Description
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
2 and 8 weeks
Title
Number of Patients With Unscheduled Hospital Visit(s)
Time Frame
from baseline to week 24 after end of treatment
Title
Percentage of Patients Satisfaction
Description
Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2.
Time Frame
24 weeks after end of treatment
Title
Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire
Description
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
Title
Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenyu Guo
Organizational Affiliation
AstraZeneca China MC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Prof. Yuan Yaozong
Organizational Affiliation
Shanghai Jiaotong University, School of Medicine, Affiliated of Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Research Site
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Research Site
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Research Site
City
Xian
State/Province
Shanxi
Country
China
Facility Name
Research Site
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Research Site
City
Beijin
Country
China
Facility Name
Research Site
City
Shanghai
Country
China
12. IPD Sharing Statement
Learn more about this trial
Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients
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