Chronic Gastritis, Non Erosive Reflux Disease
Conditions
Keywords
GI, Nexium, Phase IV, Co-diagnosed NERD
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.
Interventions
DRUGEsomeprazole
20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire. | 24 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to First Relapse. | From baseline to 24 weeks after end of treatment | 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. | 8 weeks for arm 1, 2 weeks for arm 2 | 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. | 2 and 8 weeks | 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. |
| The Success Rate in Whole Study Duration. | 24 weeks after end of treatment | 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. |
| Percentage of Patients Satisfaction | 24 weeks after end of treatment | 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 | 8 weeks | 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 | 16 weeks | 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. |
| Number of Patients With Unscheduled Hospital Visit(s) | from baseline to week 24 after end of treatment | — |
Countries
China
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Esomeprazole 8 Weeks Treatment 20 mg q.d. (quaque die) once a day dosing for 8 weeks | 154 |
| Esomeprazole 2 Weeks Treatment 20 mg q.d. (quaque die) once a day dosing for 2 weeks | 151 |
| Total | 305 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment Period | Lack of Efficacy | 18 | 25 |
Baseline characteristics
| Characteristic | Esomeprazole 2 Weeks Treatment | Esomeprazole 8 Weeks Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 140 Participants | 143 Participants | 283 Participants |
| Age Continuous | 44.9 years STANDARD_DEVIATION 13.12 | 45.9 years STANDARD_DEVIATION 12.72 | 45.4 years STANDARD_DEVIATION 12.91 |
| Region of Enrollment China | 151 participants | 154 participants | 305 participants |
| Sex: Female, Male Female | 54 Participants | 80 Participants | 134 Participants |
| Sex: Female, Male Male | 97 Participants | 74 Participants | 171 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 154 | 0 / 151 |
| serious Total, serious adverse events | 0 / 154 | 0 / 151 |
Outcome results
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.
Time frame: 24 weeks
Population: MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole 8 Weeks Treatment | Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire. | 94.9 percentage of participants |
| Esomeprazole 2 Weeks Treatment | Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire. | 87.3 percentage of participants |
Secondary
Number of Patients With Unscheduled Hospital Visit(s)
Time frame: from baseline to week 24 after end of treatment
Population: MITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole 8 Weeks Treatment | Number of Patients With Unscheduled Hospital Visit(s) | 59 participants |
| Esomeprazole 2 Weeks Treatment | Number of Patients With Unscheduled Hospital Visit(s) | 80 participants |
Secondary
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
Population: MITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Esomeprazole 8 Weeks Treatment | Percentage of Patients Satisfaction | Satisfied | 100 percentage of participants |
| Esomeprazole 8 Weeks Treatment | Percentage of Patients Satisfaction | Very satisfied | 48.5 percentage of participants |
| Esomeprazole 2 Weeks Treatment | Percentage of Patients Satisfaction | Satisfied | 96 percentage of participants |
| Esomeprazole 2 Weeks Treatment | Percentage of Patients Satisfaction | Very satisfied | 24.6 percentage of participants |
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.
Time frame: 16 weeks
Population: MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole 8 Weeks Treatment | Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire | 85.3 percentage of participants |
| Esomeprazole 2 Weeks Treatment | Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire | 80.2 percentage of participants |
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.
Time frame: 8 weeks
Population: Modified Intension To Treat defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole 8 Weeks Treatment | Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire | 80.1 percentage of participants |
| Esomeprazole 2 Weeks Treatment | Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire | 75.4 percentage of participants |
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.
Time frame: 2 and 8 weeks
Population: ITT in 8 weeks treatment group
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Esomeprazole 8 Weeks Treatment | Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group. | 2 weeks | 54.5 percentage of participants |
| Esomeprazole 8 Weeks Treatment | Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group. | 8 weeks | 88.3 percentage of participants |
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.
Time frame: 8 weeks for arm 1, 2 weeks for arm 2
Population: ITT was defined as all randomized subjects who took at least one dose of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole 8 Weeks Treatment | Symptom Relief Rate in 2 Treatment Regimens. | 88.3 percentage of participans |
| Esomeprazole 2 Weeks Treatment | Symptom Relief Rate in 2 Treatment Regimens. | 83.4 percentage of participans |
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.
Time frame: 24 weeks after end of treatment
Population: Intension to Treat (ITT) was defined as all randomized subjects who took at least one dose of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole 8 Weeks Treatment | The Success Rate in Whole Study Duration. | 83.8 percentage of participants |
| Esomeprazole 2 Weeks Treatment | The Success Rate in Whole Study Duration. | 72.8 percentage of participants |
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
Time frame: From baseline to 24 weeks after end of treatment
Population: MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Esomeprazole 8 Weeks Treatment | Time to First Relapse. | NA days |
| Esomeprazole 2 Weeks Treatment | Time to First Relapse. | 57 days |