Trial Outcomes & Findings for Efficacy of Esomeprazole in Patients With Frequent Heartburn (NCT NCT01370525)
NCT ID: NCT01370525
Last Updated: 2013-03-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
340 participants
Primary outcome timeframe
From randomisation to day 14
Results posted on
2013-03-14
Participant Flow
From total of 486 enrolled subjects, 340 subjects were randomised. From 340 subjects 171 and 169 were allocated to Esomeprazole and Placebo respectively.
Participant milestones
| Measure |
Esomeprazole
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate
|
Placebo
Placebo for Esomeprazole
|
|---|---|---|
|
Overall Study
STARTED
|
171
|
169
|
|
Overall Study
Patients Who Received Treatment
|
168
|
163
|
|
Overall Study
Patients Who Completed Treatment
|
163
|
158
|
|
Overall Study
COMPLETED
|
163
|
158
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
| Measure |
Esomeprazole
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate
|
Placebo
Placebo for Esomeprazole
|
|---|---|---|
|
Overall Study
Voluntary Discontinuation by Subject
|
2
|
3
|
|
Overall Study
Eligibility criteria not fulfilled
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Lost to follow up
|
2
|
6
|
Baseline Characteristics
Efficacy of Esomeprazole in Patients With Frequent Heartburn
Baseline characteristics by cohort
| Measure |
Esomeprazole
n=171 Participants
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
n=169 Participants
Placebo for Esomeprazole
|
Total
n=340 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
43.6 Years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
45.9 Years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
44.75 Years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
103 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
65 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN/ALASKA NATIVE
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
HISPANIC OR LATINO
|
34 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
NOT HISPANIC OR LATINO
|
56 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
NOT REPORTED
|
81 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomisation to day 14Population: Full analysis set
Outcome measures
| Measure |
Esomeprazole
n=168 Participants
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
n=163 Participants
Placebo for Esomeprazole
|
|---|---|---|
|
Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
|
43.32 Percentage
Standard Deviation 34.36
|
29.44 Percentage
Standard Deviation 29.83
|
PRIMARY outcome
Timeframe: From randomization to day 14Population: Per-protocol analysis set
Outcome measures
| Measure |
Esomeprazole
n=150 Participants
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
n=149 Participants
Placebo for Esomeprazole
|
|---|---|---|
|
Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
|
44.52 Percentage
Standard Deviation 34.4
|
31.25 Percentage
Standard Deviation 30.26
|
SECONDARY outcome
Timeframe: From randomisation to day 14Population: Full Analysis Set
Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4.
Outcome measures
| Measure |
Esomeprazole
n=168 Participants
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
n=163 Participants
Placebo for Esomeprazole
|
|---|---|---|
|
Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period
|
27 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From randomisation to the day 14Population: Full Analysis Set
The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.
Outcome measures
| Measure |
Esomeprazole
n=168 Participants
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
n=163 Participants
Placebo for 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
|
64 Participants
|
76 Participants
|
|
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
|
25 Participants
|
36 Participants
|
|
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
|
36 Participants
|
18 Participants
|
|
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
|
25 Participants
|
21 Participants
|
|
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
|
18 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From randomisation to day 14There 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.
Outcome measures
| Measure |
Esomeprazole
n=168 Participants
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
n=163 Participants
Placebo for Esomeprazole
|
|---|---|---|
|
Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment
Last 7 consecutive days
|
43 Participants
|
17 Participants
|
|
Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment
Second 7 calender days
|
43 Participants
|
16 Participants
|
|
Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment
First 7 calendar days
|
26 Participants
|
10 Participants
|
Adverse Events
Esomeprazole
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Esomeprazole
n=168 participants at risk
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
n=163 participants at risk
Placebo for Esomeprazole
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
2/168
Full analysis set (FAS) population was analyzed.
|
1.2%
2/163
Full analysis set (FAS) population was analyzed.
|
|
Gastrointestinal disorders
Nausea
|
3.0%
5/168
Full analysis set (FAS) population was analyzed.
|
1.8%
3/163
Full analysis set (FAS) population was analyzed.
|
|
Gastrointestinal disorders
Diarhhoea
|
1.2%
2/168
Full analysis set (FAS) population was analyzed.
|
2.5%
4/163
Full analysis set (FAS) population was analyzed.
|
|
Gastrointestinal disorders
Constipation
|
0.60%
1/168
Full analysis set (FAS) population was analyzed.
|
1.2%
2/163
Full analysis set (FAS) population was analyzed.
|
|
Infections and infestations
Nasopharyngitis
|
2.4%
4/168
Full analysis set (FAS) population was analyzed.
|
1.2%
2/163
Full analysis set (FAS) population was analyzed.
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.2%
2/168
Full analysis set (FAS) population was analyzed.
|
0.00%
0/163
Full analysis set (FAS) population was analyzed.
|
|
Nervous system disorders
Headache
|
2.4%
4/168
Full analysis set (FAS) population was analyzed.
|
0.00%
0/163
Full analysis set (FAS) population was analyzed.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/168
Full analysis set (FAS) population was analyzed.
|
1.2%
2/163
Full analysis set (FAS) population was analyzed.
|
|
Renal and urinary disorders
Haematuria
|
0.60%
1/168
Full analysis set (FAS) population was analyzed.
|
1.2%
2/163
Full analysis set (FAS) population was analyzed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60