Heartburn
Conditions
Keywords
Heartburn
Brief summary
This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn
Interventions
DRUGEsomeprazole
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and non-pregnant ,non-lactating females 18 years or older * Experience heartburn at least 2 days a week * Having heartburn that has responded to heartburn medication * Must discontinue any current heartburn medications
Exclusion criteria
* Having a history of erosive esophagitis verified by endoscopy * Having a history of GERD which was diagnosed by a physician * Inability to take study medication or complete the study and all study procedures * Subjects that have required more than one 14-day course of PPI treatment within the past 4 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment | From randomisation to day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period | From randomisation to the day 14 | Treatment period is considered to be both weeks 1 and 2 between V3 and V4. |
| Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo | From randomisation to day 14 | The first 4 consecutive days subjects were on randomized treatment, between V3 and V4. |
| Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment | From randomisation to day 14 | There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn. |
Countries
United States
Participant flow
Recruitment details
From total of 526 screened subjects, 341 subjects were randomised. From 341 subjects 170 and 171 were allocated to Esomeprazole and Placebo respectively.
Participants by arm
| Arm | Count |
|---|---|
| Esomeprazole Esomeprazole magnesium trihydrate 22.3 mg | 170 |
| Placebo Placebo for Esomeprazole | 171 |
| Total | 341 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Development of study specific withdrawal | 1 | 1 |
| Overall Study | Eligibility criteria not fulfilled | 0 | 1 |
| Overall Study | Lost to follow up | 6 | 10 |
| Overall Study | Protocol Violation | 8 | 5 |
| Overall Study | Voluntary Discontinuation by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | Esomeprazole |
|---|---|---|---|
| Age Continuous All | 42.8 Years STANDARD_DEVIATION 13.2 | 42.2 Years STANDARD_DEVIATION 13.6 | 41.6 Years STANDARD_DEVIATION 14 |
| Race/Ethnicity, Customized AMERICAN INDIAN/ALASKA NATIVE | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 50 Participants | 102 Participants | 52 Participants |
| Race/Ethnicity, Customized HISPANIC OR LATINO | 25 Participants | 49 Participants | 24 Participants |
| Race/Ethnicity, Customized NATIVE HAWAIIAN/PACIFIC ISLANDER | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized NOT HISPANIC OR LATINO | 46 Participants | 101 Participants | 55 Participants |
| Race/Ethnicity, Customized NOT REPORTED | 100 Participants | 191 Participants | 91 Participants |
| Race/Ethnicity, Customized OTHER | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized WHITE | 120 Participants | 231 Participants | 111 Participants |
| Sex: Female, Male Female | 87 Participants | 178 Participants | 91 Participants |
| Sex: Female, Male Male | 84 Participants | 163 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 162 | 15 / 158 |
| serious Total, serious adverse events | 0 / 162 | 0 / 158 |
Outcome results
Primary
Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
Time frame: From randomisation to day 14
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole | Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment | 46.79 Percentage of heartburn free days | Standard Deviation 33.32 |
| Placebo | Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment | 30.93 Percentage of heartburn free days | Standard Deviation 28.86 |
Primary
Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
Time frame: From randomisation to day 14
Population: Per-protocol analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esomeprazole | Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment | 47.82 Percentage of heartburn free days | Standard Deviation 33.23 |
| Placebo | Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment | 28.83 Percentage of heartburn free days | Standard Deviation 31.22 |
Secondary
Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo
The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.
Time frame: From randomisation to day 14
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Esomeprazole | Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo | Zero days | 55 Participants |
| Esomeprazole | Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo | Three days | 37 Participants |
| Esomeprazole | Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo | One day | 32 Participants |
| Esomeprazole | Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo | Four days | 16 Participants |
| Esomeprazole | Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo | Two days | 22 Participants |
| Placebo | Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo | Four days | 2 Participants |
| Placebo | Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo | One day | 34 Participants |
| Placebo | Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo | Two days | 29 Participants |
| Placebo | Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo | Three days | 16 Participants |
| Placebo | Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo | Zero days | 77 Participants |
Secondary
Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period
Treatment period is considered to be both weeks 1 and 2 between V3 and V4.
Time frame: From randomisation to the day 14
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole | Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period | 27 Participants |
| Placebo | Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period | 2 Participants |
Secondary
Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment
There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.
Time frame: From randomisation to day 14
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Esomeprazole | Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment | Last 7 consecutive days | 40 Participants |
| Esomeprazole | Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment | Second 7 calendar days | 38 Participants |
| Esomeprazole | Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment | First 7 calendar days | 32 Participants |
| Placebo | Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment | Last 7 consecutive days | 17 Participants |
| Placebo | Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment | Second 7 calendar days | 13 Participants |
| Placebo | Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment | First 7 calendar days | 7 Participants |