Heartburn
Conditions
Keywords
Patients, Single
Brief summary
Administration of esomeprazole 40 mg to subjects who still had heartburn after receiving rabeprazole 20 mg once daily for 4 to 8 weeks will result in statistically significant improvement of heartburn after 8-week treatment.
Interventions
esomeprazole 40 mg once daily, 8 weeks
Sponsors
Quintiles, Inc.
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 or female aged 20 years or more * Documented history of reflux esophagitis verified by endoscopy in the past, including the grade of Los Angeles (LA) classification (Lundell LR et al 1999) before treatment * Ongoing (until date of Visit 1) treatment with rabeprazole 20 mg, given once daily, for a period of 4 to 8 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 during the past 7 days prior to Visit 1, judged by the investigator(s) as follows: At least 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities) OR At least 4 days with symptoms including mild ones (i.e. awareness of sign or symptom, but easily tolerated). * The subject needs to be able to understand and read the official languages of the country.
Exclusion criteria
* Use of other PPIs and/or H2RA during rabeprazole treatment * Previous use of esomeprazole 40 mg during the 12 weeks before enrolment * Current or historical evidence of gastrointestinal pathology * History, signs or symptoms of clinically significant or uncontrolled cardiovascular, pulmonary, renal, endocrine, hematologic, neurologic, psychiatric pancreatic or hepatic disease as judged by the investigator to interfere with the conduct of the study, the interpretation of study results, subject compliance, or the health of the subject during the study. * Documented upper gastrointestinal surgery such as gastric resection, vagotomy and/or pyloroplasty, hiatus hernia surgery or fundoplication. Note: endoscopic polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection or simple suturing of an ulcer are not
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 to 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 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 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 Frequency 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 Frequency of Heartburn During the 7-day Period Prior to Baseline (Visit 1) | Baseline to 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. |
Countries
China
Participant flow
Recruitment details
First participant enrolled on 23 November 2010. Last participant completed on 11 June 2011. Out of 101 enrolled participants, 100 participants (target was 100) received esomeprazole 40 mg. All of the participants were included in safety analysis set and 96 out of the 100 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 20 mg were included in this study.
Participants by arm
| Arm | Count |
|---|---|
| Esomeprazole 40 mg esomeprazole 40 mg once daily, 8 weeks | 101 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Sponsor Decision | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Esomeprazole 40 mg |
|---|---|
| Age Continuous | 51.2 Year STANDARD_DEVIATION 13.71 |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 100 |
| serious Total, serious adverse events | 0 / 100 |
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 to 8 weeks
Population: Full analysis set (96 participants)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Esomeprazole 40 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) | -3.3 Number of days | Standard Deviation 2.36 |
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 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 4 weeks was analysed.
Time frame: Baseline and 4 weeks
Population: 92 Participants in the Full analysis set (96 participants) had data of heartburn.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - Esomeprazole 40 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) | -2.6 Number of days | Standard Deviation 2.82 |
Secondary
Change in the Maximum Severity 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)
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: 92 Participants in the Full analysis set (96 participants) had data of heartburn at week 4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 - Esomeprazole 40 mg | Change in the Maximum Severity 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) | Improved | 77 Participants |
| Arm 1 - Esomeprazole 40 mg | Change in the Maximum Severity 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) | Unchanged | 14 Participants |
| Arm 1 - Esomeprazole 40 mg | Change in the Maximum Severity 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) | 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 Frequency 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 to 8 weeks
Population: Full analysis set (96 participants)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1 - Esomeprazole 40 mg | Change in the Maximum Severity 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) | Improved | 83 Participants |
| Arm 1 - Esomeprazole 40 mg | Change in the Maximum Severity 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) | Unchanged | 12 Participants |
| Arm 1 - Esomeprazole 40 mg | Change in the Maximum Severity 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) | Worsened | 1 Participants |