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
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.
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 |
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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