A Phase 4 interventional study of Optimal Dosing of Omeprazole in Heartburn, sponsored by MetroHealth Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-25.
Sponsored by MetroHealth Medical Center · Phase 4, Interventional, and Treatment
The overall aim of this study is to assess if patients with persistent gastroesophageal reflux disease (GERD) symptoms receiving sub-optimal omeprazole dosing experience improvement in GERD symptoms when prescribed an optimal dosing regimen. The optimal dosing regimen is defined as taking omeprazole 30 minutes prior to the first meal of the day.
GERD remains a common gastrointestinal complaint, resulting in 6% of outpatient visits. The economic burden is significant with direct costs exceeding $12 billion/year and indirect cost as high as $75 billion/year. The primary aim of this study was determine whether a brief educational intervention optimizing proton pump inhibitor (PPI) dosing would reduce GERD symptoms using the gastroesophageal reflux disease symptom assessment scale (GSAS) questionnaire. Further, secondary analysis would utilize the results of the trial and combine them with costs related to uncontrolled GERD to estimated the potential economic impact.
154 studies on the registry are indexed under Heartburn; 12 are open to participants now.
This study's enrollment of 64 is below the median of 100 across 127 interventional studies indexed under Heartburn.
Browse Heartburn studies →MetroHealth Medical Center is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
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Exclusion Criteria:
No change will be made to the sub-optimal dosing regimen of omeprazole 20 mg. Rescue antacid use is permitted. Total duration of 6 weeks.
Patients will be administered optimal dosing regimen of Omeprazole 20 mg for 4 weeks starting at week 2. Rescue antacid use is permitted. Total duration of 6 weeks.
Drug: Optimal Dosing of Omeprazole
Omeprazole 20 mg
Also known as: omeprazole
Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall)
The 15-symptom GSAS questionnaire includes measures of: Gastrointestinal distress, Regurgitation/heartburn and Upper respiratory manifestations. The outcome measures were the number, frequency, and severity of GSAS symptoms reported at 6 weeks. Measures were based on aggregate GSAS scores. Symptom numbers range from 0 to 15. Frequency is based on the total number of reported days of symptomatic episodes in the past week divided by the number of potential symptoms (number reported divided by 15 for GSAS score. The range for frequency score:0 to 7 with higher scores indicative of greater frequency of symptoms. Severity is the average distress score reported by individuals (zero if no symptoms). Symptom distress is based on a 4 point Likert scale (0= not at all, 1=somewhat, 2=quite a bit and 3=very much). The higher the score the worse outcome. .
Time frame: 6 weeks
| Milestone | Sub-optimal Dosing | Optimal Dosing |
|---|---|---|
| Started | 40 | 24 |
| Completed | 38 | 22 |
| Not completed | 2 | 2 |
The 15-symptom GSAS questionnaire includes measures of: Gastrointestinal distress, Regurgitation/heartburn and Upper respiratory manifestations. The outcome measures were the number, frequency, and severity of GSAS symptoms reported at 6 weeks. Measures were based on aggregate GSAS scores. Symptom numbers range from 0 to 15. Frequency is based on the total number of reported days of symptomatic episodes in the past week divided by the number of potential symptoms (number reported divided by 15 for GSAS score. The range for frequency score:0 to 7 with higher scores indicative of greater frequency of symptoms. Severity is the average distress score reported by individuals (zero if no symptoms). Symptom distress is based on a 4 point Likert scale (0= not at all, 1=somewhat, 2=quite a bit and 3=very much). The higher the score the worse outcome. .
| score on a scale | Sub-optimal Dosing | Optimal Dosing |
|---|---|---|
| GSAS Symptoms Score | 8.5 ± 0.7 | 5.2 ± 0.5 |
| GSAS Frequency Score | 2.2 ± 0.3 | 1.0 ± 0.2 |
| GSAS Severity Score | 1.0 ± 0.1 | 0.6 ± 0.1 |
Collected over Adverse event and/or serious adverse event data were collected for 1 year after study enrollment for each study participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sub-optimal Dosing | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Optimal Dosing | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Age, Continuous(years) | Sub-optimal Dosing | Optimal Dosing | Total |
|---|---|---|---|
| Mean | 49.9 ± 12.2 | 52.3 ± 13.4 | 51.1 ± 12.5 |
| Sex: Female, Male(Participants) | Sub-optimal Dosing | Optimal Dosing | Total |
|---|---|---|---|
| Female | 23 | 15 | 38 |
| Male | 17 | 9 | 26 |
| Region of Enrollment(Participants) | Sub-optimal Dosing | Optimal Dosing | Total |
|---|---|---|---|
| United States | 40 | 24 | 64 |
The record gives a start of Aug 2014, a primary completion of Dec 2015 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2022, 6 years 10 months after primary completion.
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Studies of the drug tested here: Omeprazole