A Phase 4 interventional study of Esomeprazole 20 mg and Placebo in Heartburn, sponsored by Pfizer. Completed at 2 sites in United States. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-04-19.
Sponsored by Pfizer · Phase 4, Interventional, and Basic science
Among 19 studies testing esomeprazole in Heartburn — none open to participants now, none under way, none of them phase 3. Esomeprazole · Heartburn.
Among the 19 studies testing esomeprazole in Heartburn, this one is the 17th largest by enrollment, is the only one that started in 2016, is one of 15 in phase 4, and was the 19th registered.
154 studies on the registry are indexed under Heartburn; 12 are open to participants now.
Browse Heartburn studies →None of the 19 studies testing esomeprazole in Heartburn is open now. The open studies under Heartburn, anywhere →
Esomeprazole: first FDA approval 2001 (NEXIUM), first EMA approval 2013. What it is approved for, and how studies give it, is on its page →
Of the 8 Heartburn studies recruiting now, 5 set no upper age limit and 3 stop at 75 or younger; 2 take children under 18; 1 takes healthy volunteers.
This study: 22 Years to 65 Years · all sexes · no healthy volunteers.
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19 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2016.
This study's enrollment of 55 is below the median of 100 across 127 interventional studies indexed under Heartburn.
Median enrollment 248 across the 19 interventional studies. Of the 18 that completed or were terminated, 7 (39%) have results posted.
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18 of 19 have an industry lead sponsor. The 5 most frequent:
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
Pfizer has 1 study filed under Heartburn — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 19 studies testing esomeprazole in Heartburn, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this pilot study is to investigate the association between gastric acid suppression and relief of 24 hour heartburn following treatment with the proton pump inhibitor (PPI) drug esomeprazole in frequent heartburn patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Esomeprazole 20 mg administered orally in the morning and placebo administered orally in the evening
Drug: Esomeprazole 20 mg · Drug: Placebo
Esomeprazole 20 mg administered orally in the morning and esomeprazole 20 mg administered orally in the evening
Drug: Esomeprazole 20 mg
Placebo administered orally in the morning and placebo administered orally in the evening
Drug: Placebo
Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)
Also known as: Nexium
Placebo capsules
Number of Participants With Relief of 24 Hour Heartburn and Without Relief of 24 Hour Heartburn
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.
Time frame: Day 8 up to Day 14
Change From Baseline at Day 14 in Percentage of Time Over 24--Hour Period With Intra Gastric pH Greater Than (>)4
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.
Time frame: Baseline, Day 14
| Milestone | Esomeprazole 20 mg Twice Daily | Esomeprazole 20 mg Once Daily + Placebo | Placebo |
|---|---|---|---|
| Started | 21 | 22 | 12 |
| Completed | 20 | 22 | 12 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 |
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.
| participants | Esomeprazole 20 mg Twice Daily | Esomeprazole 20 mg Once Daily + Placebo | Placebo |
|---|---|---|---|
| With Relief | 7 | 10 | 0 |
| Without Relief | 9 | 8 | 5 |
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.
| percentage of time | Esomeprazole 20 mg Twice Daily | Esomeprazole 20 mg Once Daily + Placebo | Placebo |
|---|---|---|---|
| Baseline | 12.53 ± 18.045 | 13.35 ± 9.069 | 12.32 ± 5.635 |
| Change at Day 14 | 70.23 ± 23.105 | 42.83 ± 18.654 | 0.78 ± 5.839 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Esomeprazole 20 mg Twice Daily | — | 0/21 (0%) | 3/21 (14.3%) |
| Esomeprazole 20 mg Once Daily + Placebo | — | 0/22 (0%) | 1/22 (4.5%) |
| Placebo | — | 0/12 (0%) | 2/12 (16.7%) |
| Event | Esomeprazole 20 mg Twice Daily | Esomeprazole 20 mg Once Daily + Placebo | Placebo |
|---|---|---|---|
| GastroenteritisInfections and infestations | 0/21 | 0/22 | 2/12 |
| Upper respiratory tract infectionInfections and infestations | 2/21 | 1/22 | 0/12 |
| MigraineNervous system disorders | 1/21 | 0/22 | 0/12 |
| NephrolithiasisRenal and urinary disorders | 1/21 | 0/22 | 0/12 |
| Gastroenteritis viralInfections and infestations | 0/21 | 1/22 | 0/12 |
Safety population included all participants who received at least 1 dose of study medication.
| Age, Continuous(years) | Esomeprazole 20 mg Twice Daily | Esomeprazole 20 mg Once Daily + Placebo | Placebo | Total |
|---|---|---|---|---|
| Mean | 41.6 ± 10.23 | 40.8 ± 10.95 | 44.7 ± 10.50 | 41.9 ± 10.49 |
| Sex: Female, Male(Participants) | Esomeprazole 20 mg Twice Daily | Esomeprazole 20 mg Once Daily + Placebo | Placebo | Total |
|---|---|---|---|---|
| Female | 11 | 14 | 9 | 34 |
| Male | 10 | 8 | 3 | 21 |
The record gives a start of Jan 2016, a primary completion of Apr 2016 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2017, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Esomeprazole