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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esomeprazole 8 weeks treatment | Active Comparator | 20 mg q.d. (quaque die) once a day dosing for 8 weeks |
|
| Esomeprazole 2 Weeks Treatment | Active Comparator | 20 mg q.d. (quaque die) once a day dosing for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | 20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenyu Guo | AstraZeneca China MC | Study Director |
| Prof. Yuan Yaozong | Shanghai Jiaotong University, School of Medicine, Affiliated of Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Guangzhou | Guangdong | China | |||
| Research Site |
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Three hundred and five patients, out of the 311 patients who signed the informed consent, were randomized to receive 8 weeks (n=154) or 2 weeks (n=151) of esomeprazole treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole 8 Weeks Treatment | 20 mg q.d. (quaque die) once a day dosing for 8 weeks |
| FG001 | Esomeprazole 2 Weeks Treatment | 20 mg q.d. (quaque die) once a day dosing for 2 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
|
| ||||||||||||||||||
| Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Esomeprazole 8 Weeks Treatment | 20 mg q.d. (quaque die) once a day dosing for 8 weeks |
| BG001 | Esomeprazole 2 Weeks Treatment | 20 mg q.d. (quaque die) once a day dosing for 2 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment | Posted | Number | percentage of participants | 24 weeks |
|
From baseline to 24 weeks after treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Esomeprazole 8 Weeks Treatment | 20 mg q.d. (quaque die) once a day dosing for 8 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | az_trials_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D000096663 | Non-Erosive Reflux Disease |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Esomeprazole | Drug | 20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up |
|
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 |
| Wuhan |
| Hubei |
| China |
| Research Site | Nanjing | Jiangsu | China |
| Research Site | Jinan | Shandong | China |
| Research Site | Xian | Shanxi | China |
| Research Site | Hangzhou | Zhejiang | China |
| Research Site | Beijin | China |
| Research Site | Shanghai | China |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Esomeprazole 2 Weeks Treatment | 20 mg q.d. (quaque die) once a day dosing for 2 weeks |
|
|
| Secondary | 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. | Intension to Treat (ITT) was defined as all randomized subjects who took at least one dose of treatment. | Posted | Number | percentage of participants | 24 weeks after end of treatment |
|
|
|
| Secondary | 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 | MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment. | Posted | Median | Inter-Quartile Range | days | From baseline to 24 weeks after end of treatment |
|
|
|
| Secondary | 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. | ITT was defined as all randomized subjects who took at least one dose of treatment. | Posted | Number | percentage of participans | 8 weeks for arm 1, 2 weeks for arm 2 |
|
|
|
| Secondary | 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. | ITT in 8 weeks treatment group | Posted | Number | percentage of participants | 2 and 8 weeks |
|
|
|
| Secondary | Number of Patients With Unscheduled Hospital Visit(s) | MITT | Posted | Number | participants | from baseline to week 24 after end of treatment |
|
|
|
| Secondary | Percentage of Patients Satisfaction | Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2. | MITT | Posted | Number | percentage of participants | 24 weeks after end of treatment |
|
|
|
| Secondary | 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. | Modified Intension To Treat defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment | Posted | Number | percentage of participants | 8 weeks |
|
|
|
| Secondary | 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. | MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment. | Posted | Number | percentage of participants | 16 weeks |
|
|
|
| 0 |
| 154 |
| 0 |
| 154 |
| EG001 | Esomeprazole 2 Weeks Treatment | 20 mg q.d. (quaque die) once a day dosing for 2 weeks | 0 | 151 | 0 | 151 |
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| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |