Trial Outcomes & Findings for Efficacy of Esomeprazole in Patients With Frequent Heartburn (NCT NCT01370538)
NCT ID: NCT01370538
Last Updated: 2013-04-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
341 participants
Primary outcome timeframe
From randomisation to day 14
Results posted on
2013-04-11
Participant Flow
From total of 526 screened subjects, 341 subjects were randomised. From 341 subjects 170 and 171 were allocated to Esomeprazole and Placebo respectively.
Participant milestones
| Measure |
Esomeprazole
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
Placebo for Esomeprazole
|
|---|---|---|
|
Overall Study
STARTED
|
170
|
171
|
|
Overall Study
Patients Who Received Treatment
|
165
|
161
|
|
Overall Study
Patients Who Completed Treatment
|
151
|
152
|
|
Overall Study
COMPLETED
|
151
|
152
|
|
Overall Study
NOT COMPLETED
|
19
|
19
|
Reasons for withdrawal
| Measure |
Esomeprazole
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
Placebo for Esomeprazole
|
|---|---|---|
|
Overall Study
Voluntary Discontinuation by Subject
|
3
|
2
|
|
Overall Study
Eligibility criteria not fulfilled
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Protocol Violation
|
8
|
5
|
|
Overall Study
Development of study specific withdrawal
|
1
|
1
|
|
Overall Study
Lost to follow up
|
6
|
10
|
Baseline Characteristics
Efficacy of Esomeprazole in Patients With Frequent Heartburn
Baseline characteristics by cohort
| Measure |
Esomeprazole
n=170 Participants
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
n=171 Participants
Placebo for Esomeprazole
|
Total
n=341 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
All
|
41.6 Years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
42.8 Years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
42.2 Years
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
111 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
NATIVE HAWAIIAN/PACIFIC ISLANDER
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN/ALASKA NATIVE
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
HISPANIC OR LATINO
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
NOT HISPANIC OR LATINO
|
55 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
NOT REPORTED
|
91 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomisation to day 14Population: Full analysis set
Outcome measures
| Measure |
Esomeprazole
n=162 Participants
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
n=158 Participants
Placebo for 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
|
30.93 Percentage of heartburn free days
Standard Deviation 28.86
|
PRIMARY outcome
Timeframe: From randomisation to day 14Population: Per-protocol analysis set
Outcome measures
| Measure |
Esomeprazole
n=142 Participants
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
n=140 Participants
Placebo for 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
|
28.83 Percentage of heartburn free days
Standard Deviation 31.22
|
SECONDARY outcome
Timeframe: From randomisation to the day 14Population: Full Analysis Set
Treatment period is considered to be both weeks 1 and 2 between V3 and V4.
Outcome measures
| Measure |
Esomeprazole
n=162 Participants
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
n=158 Participants
Placebo for Esomeprazole
|
|---|---|---|
|
Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period
|
27 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From randomisation to day 14Population: Full Analysis Set
The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.
Outcome measures
| Measure |
Esomeprazole
n=162 Participants
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
n=158 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
|
55 Participants
|
77 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
|
32 Participants
|
34 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
|
22 Participants
|
29 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
|
37 Participants
|
16 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
|
16 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From randomisation to day 14Population: Full Analysis Set
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.
Outcome measures
| Measure |
Esomeprazole
n=162 Participants
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
n=158 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
|
40 Participants
|
17 Participants
|
|
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
|
13 Participants
|
|
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
|
7 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=162 participants at risk
Esomeprazole magnesium trihydrate 22.3 mg
|
Placebo
n=158 participants at risk
Placebo for Esomeprazole
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.1%
5/162
Full analysis set (FAS) population was analyzed.
|
2.5%
4/158
Full analysis set (FAS) population was analyzed.
|
|
Gastrointestinal disorders
Constipation
|
2.5%
4/162
Full analysis set (FAS) population was analyzed.
|
0.00%
0/158
Full analysis set (FAS) population was analyzed.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
4/162
Full analysis set (FAS) population was analyzed.
|
1.9%
3/158
Full analysis set (FAS) population was analyzed.
|
|
Gastrointestinal disorders
Dry mouth
|
0.62%
1/162
Full analysis set (FAS) population was analyzed.
|
1.3%
2/158
Full analysis set (FAS) population was analyzed.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/162
Full analysis set (FAS) population was analyzed.
|
1.3%
2/158
Full analysis set (FAS) population was analyzed.
|
|
General disorders
Pain
|
0.00%
0/162
Full analysis set (FAS) population was analyzed.
|
1.9%
3/158
Full analysis set (FAS) population was analyzed.
|
|
General disorders
Pyrexia
|
0.00%
0/162
Full analysis set (FAS) population was analyzed.
|
1.3%
2/158
Full analysis set (FAS) population was analyzed.
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
2/162
Full analysis set (FAS) population was analyzed.
|
1.3%
2/158
Full analysis set (FAS) population was analyzed.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
2/162
Full analysis set (FAS) population was analyzed.
|
1.3%
2/158
Full analysis set (FAS) population was analyzed.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
2/162
Full analysis set (FAS) population was analyzed.
|
0.63%
1/158
Full analysis set (FAS) population was analyzed.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.62%
1/162
Full analysis set (FAS) population was analyzed.
|
1.3%
2/158
Full analysis set (FAS) population was analyzed.
|
|
Investigations
Blood glucose decreased
|
1.2%
2/162
Full analysis set (FAS) population was analyzed.
|
0.63%
1/158
Full analysis set (FAS) population was analyzed.
|
|
Investigations
Blood glucose increased
|
0.62%
1/162
Full analysis set (FAS) population was analyzed.
|
1.3%
2/158
Full analysis set (FAS) population was analyzed.
|
|
Investigations
Haemoglobin decreased
|
1.2%
2/162
Full analysis set (FAS) population was analyzed.
|
0.63%
1/158
Full analysis set (FAS) population was analyzed.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/162
Full analysis set (FAS) population was analyzed.
|
1.3%
2/158
Full analysis set (FAS) population was analyzed.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.9%
3/162
Full analysis set (FAS) population was analyzed.
|
0.00%
0/158
Full analysis set (FAS) population was analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.9%
3/162
Full analysis set (FAS) population was analyzed.
|
0.63%
1/158
Full analysis set (FAS) population was analyzed.
|
|
Nervous system disorders
Headache
|
1.2%
2/162
Full analysis set (FAS) population was analyzed.
|
1.3%
2/158
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