Trial Outcomes & Findings for Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment (NCT NCT02708355)
NCT ID: NCT02708355
Last Updated: 2017-04-19
Results Overview
Relief of 24 hour heartburn was defined as a daily diary response of "0" to the question "Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?" on at least 6 of the participant's last 7 consecutive days \[Days 8 - 14\] of treatment allowing for one day with a maximum severity of "2".The response was noted by participants in the diary for last 7 consecutive days \[Day 8 - 14\] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome measure, participants with relief of 24 hour heartburn and participants without relief of 24 hour heartburn were reported.
COMPLETED
PHASE4
55 participants
Day 8 up to Day 14
2017-04-19
Participant Flow
Participant milestones
| Measure |
Esomeprazole 20 mg Twice Daily
Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
|
Esomeprazole 20 mg Once Daily + Placebo
Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
|
Placebo
Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
12
|
|
Overall Study
COMPLETED
|
20
|
22
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Esomeprazole 20 mg Twice Daily
Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
|
Esomeprazole 20 mg Once Daily + Placebo
Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
|
Placebo
Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment
Baseline characteristics by cohort
| Measure |
Esomeprazole 20 mg Twice Daily
n=21 Participants
Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
|
Esomeprazole 20 mg Once Daily + Placebo
n=22 Participants
Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
|
Placebo
n=12 Participants
Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 10.23 • n=5 Participants
|
40.8 years
STANDARD_DEVIATION 10.95 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 10.50 • n=5 Participants
|
41.9 years
STANDARD_DEVIATION 10.49 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 8 up to Day 14Population: Per protocol analysis set included all randomized participants who provided valid data for Day -1 PH monitoring, take at least one dose of randomized study medication, complete the 14 day treatment phase, undergo and provide valid data for Day 14 pH monitoring and complete at least 5 days of diary entries in each of Days -7 to -1 and Days 8 to 14.
Relief of 24 hour heartburn was defined as a daily diary response of "0" to the question "Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?" on at least 6 of the participant's last 7 consecutive days \[Days 8 - 14\] of treatment allowing for one day with a maximum severity of "2".The response was noted by participants in the diary for last 7 consecutive days \[Day 8 - 14\] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome measure, participants with relief of 24 hour heartburn and participants without relief of 24 hour heartburn were reported.
Outcome measures
| Measure |
Esomeprazole 20 mg Twice Daily
n=16 Participants
Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
|
Esomeprazole 20 mg Once Daily + Placebo
n=18 Participants
Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
|
Placebo
n=5 Participants
Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
|
|---|---|---|---|
|
Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn
With Relief
|
7 participants
|
10 participants
|
0 participants
|
|
Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn
Without Relief
|
9 participants
|
8 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Baseline, Day 14Population: Per protocol analysis set included all randomized participants who provided valid data for Day -1 PH monitoring, take at least one dose of randomized study medication, complete the 14 day treatment phase, undergo and provide valid data for Day 14 pH monitoring and complete at least 5 days of diary entries in each of Days -7 to -1 and Days 8 to 14.
Percentage of time was calculated over the 24 hour period during which intra gastric pH \>4 was observed. Relief of 24 hour heartburn was defined as a daily diary response of "0" to the question "Over the last 24 hours (yesterday and last night), what was the severity of your most intense episode of heartburn?" on at least 6 of the participant's last 7 consecutive days \[Days 8 - 14\] of treatment allowing for one day with a maximum severity of "2".The response was noted by participants in the diary for last 7 consecutive days \[Day 8 - 14\] on a 3 point scale ranged from 0 to 2 where 0= complete relief and 2= maximum severity. Higher score indicated worse condition/more severity. In this outcome, change from baseline at Day 14 in percentage of time over the 24 hour period during which intra gastric pH \>4 was observed, was reported.
Outcome measures
| Measure |
Esomeprazole 20 mg Twice Daily
n=16 Participants
Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
|
Esomeprazole 20 mg Once Daily + Placebo
n=18 Participants
Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
|
Placebo
n=5 Participants
Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
|
|---|---|---|---|
|
Change From Baseline at Day 14 in Percentage of Time Over 24--Hour Period With Intra Gastric pH Greater Than (>)4
Baseline
|
12.53 percentage of time
Standard Deviation 18.045
|
13.35 percentage of time
Standard Deviation 9.069
|
12.32 percentage of time
Standard Deviation 5.635
|
|
Change From Baseline at Day 14 in Percentage of Time Over 24--Hour Period With Intra Gastric pH Greater Than (>)4
Change at Day 14
|
70.23 percentage of time
Standard Deviation 23.105
|
42.83 percentage of time
Standard Deviation 18.654
|
0.78 percentage of time
Standard Deviation 5.839
|
Adverse Events
Esomeprazole 20 mg Twice Daily
Esomeprazole 20 mg Once Daily + Placebo
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Esomeprazole 20 mg Twice Daily
n=21 participants at risk
Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
|
Esomeprazole 20 mg Once Daily + Placebo
n=22 participants at risk
Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
|
Placebo
n=12 participants at risk
Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
|
|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/21
|
0.00%
0/22
|
16.7%
2/12
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/21
|
4.5%
1/22
|
0.00%
0/12
|
|
Infections and infestations
Upper respiratory tract infection
|
9.5%
2/21
|
4.5%
1/22
|
0.00%
0/12
|
|
Nervous system disorders
Migraine
|
4.8%
1/21
|
0.00%
0/22
|
0.00%
0/12
|
|
Renal and urinary disorders
Nephrolithiasis
|
4.8%
1/21
|
0.00%
0/22
|
0.00%
0/12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER