Gastroesophageal Reflux Disease, GERD, Reflux Esophagitis
Conditions
Keywords
esomeprazole 20mg, heartburn, rabeprazole 10mg, reflux esophagitis, Phase IV
Brief summary
Administration of esomeprazole 20 mg to subjects who still had heartburn after receiving rabeprazole 10 mg once daily for at least 4 weeks will result in statistically significant improvement of heartburn after 8-week treatment.
Interventions
esomeprazole 20 mg once daily for 8 weeks
Sponsors
Parexel
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male of female aged 20 years or more * History of reflux esophagitis * Ongoing (until date of Visit 1) treatment with rabeprazole 10 mg, given once daily, for at least 4 weeks.The subject must take rabeprazole at least 4 days a week in the past 7 days prior to Visit 1. * Persisting symptoms of heartburn experienced at least 2 days during the past 7 days prior to Visit 1.
Exclusion criteria
* Use of other PPIs and/or H2RA during rabeprazole treatment * History or having other gastrointestinal diseases * History of upper gastrointestinal surgery * Initiation of medications that can affect digestive functions within 4 weeks before study treatment * Inability to complete questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | Baseline and 8 weeks | The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | Baseline and 4 weeks | The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 2) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed. |
| Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | Baseline and 4 weeks. | Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened. |
| Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | Baseline and 8 weeks | Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened. |
Participant flow
Recruitment details
First participant enrolled on 25 August 2011. Last participant completed on 31 January 2012. Out of 108 enrolled participants, 107 participants (target was 100) received esomeprazole 20 mg. All of the participants were included in safety analysis set and 104 out of the 107 participants were included in the full analysis set for efficacy analyses.
Pre-assignment details
Participants with a history of reflux oesophagitis and with continuing heartburn after previous treatment with rabeprazole 10 mg were included in this study.
Participants by arm
| Arm | Count |
|---|---|
| Esomeprazole 20 mg esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks | 104 |
| Total | 104 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Severe Non-Compliance to Protocol | 1 |
| Overall Study | Used other proton pump inhibitor | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Esomeprazole 20 mg |
|---|---|
| Age Continuous | 50.9 years STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 107 |
| serious Total, serious adverse events | 2 / 107 |
Outcome results
Primary
Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
The number of days with heartburn during the 7-day period prior to the 8 week visit (Visit 3) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 8 weeks was analysed.
Time frame: Baseline and 8 weeks
Population: Efficacy Population (104 participants)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole 20 mg | Change in the Frequency of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | -3.0 Days with heartburn | Standard Deviation 2.4 |
Comparison: Wilcoxon signed-rank test was used to check whether the change in the frequency of heartburn during the 7-day period prior to the 8 week visit (Visit 3) compared to the frequency of heartburn during the 7-day period prior to baseline (Visit 1) was statistically significant or not.p-value: <0.001Wilocoxon signed-rank test
Secondary
Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
The number of days with heartburn during the 7-day period prior to the 4 week visit (Visit 2) was compared to the number of days with heartburn during the 7-day period prior to baseline (Visit 1). The difference in the number of days with heartburn from baseline to 4 weeks was analysed.
Time frame: Baseline and 4 weeks
Population: 101 Participants out of efficacy population (104 participants) who had data related to heartburn at Week 4 were used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole 20 mg | Change in the Frequency of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | -2.4 Days with heartburn | Standard Deviation 2.8 |
Secondary
Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
Maximum severity of heartburn during 7 days at baseline and at 4 weeks was obtained (None, Mild, Moderate, Severe). If the value at 4 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened.
Time frame: Baseline and 4 weeks.
Population: 101 Participants out of efficacy population (104 participants) who had data related to heartburn at Week 4 were used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Esomeprazole 20 mg | Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | Improved | 76 Participants |
| Esomeprazole 20 mg | Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | Unchanged | 24 Participants |
| Esomeprazole 20 mg | Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 4 Week Visit (Visit 2) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | Worsened | 1 Participants |
Secondary
Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1).
Maximum severity of heartburn during 7 days at baseline and at 8 weeks was obtained (None, Mild, Moderate, Severe). If the value at 8 weeks was better than at baseline in a participant, the participant was s categorized into Improved. If the value was same, then categorised into Unchanged. If the value was worsened, categorised into Worsened.
Time frame: Baseline and 8 weeks
Population: Efficacy Population (104 participants)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Esomeprazole 20 mg | Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | Improved | 84 Participants |
| Esomeprazole 20 mg | Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | Unchanged | 18 Participants |
| Esomeprazole 20 mg | Change in the Maximum Severity of Heartburn During the 7-day Period Prior to the 8 Week Visit (Visit 3) Compared to the Maximum Severity of Heartburn During the 7-day Period Prior to Baseline (Visit 1). | Worsened | 2 Participants |