Heartburn
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGOptimal Dosing of Omeprazole
Omeprazole 20 mg
Sponsors
MetroHealth Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* ≥ 18 years old * taking omeprazole 20 mg * episodic heartburn at least 3 times per week * provides consent and be willing to complete study questionnaires * read, speak and write English
Exclusion criteria
* weight loss (alarm symptom) * normal esophagogastroduodenoscopy (EGD) in last one year * pregnant or women planning on becoming pregnant at any time during the study * history of Barrett's esophagus * prior esophageal strictures * intolerance/allergy to study medications * patients on plavix or a history of upper gastrointestinal surgery * investigators or their immediate family (spouse, children, sibling)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall) | 6 weeks | 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. . |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sub-optimal Dosing 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. | 40 |
| Optimal Dosing Patients will be administered optimal regimen dosing of Omeprazole 20 mg for 4 weeks starting at week 2. Rescue antacid use is permitted. Total duration of 6 weeks.
Optimal Dosing of Omeprazole: Omeprazole 20 mg | 24 |
| Total | 64 |
Baseline characteristics
| Characteristic | Sub-optimal Dosing | Optimal Dosing | Total |
|---|---|---|---|
| Age, Continuous | 49.9 years STANDARD_DEVIATION 12.2 | 52.3 years STANDARD_DEVIATION 13.4 | 51.1 years STANDARD_DEVIATION 12.5 |
| Region of Enrollment United States | 40 Participants | 24 Participants | 64 Participants |
| Sex: Female, Male Female | 23 Participants | 15 Participants | 38 Participants |
| Sex: Female, Male Male | 17 Participants | 9 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 24 |
| other Total, other adverse events | 0 / 40 | 0 / 24 |
| serious Total, serious adverse events | 0 / 40 | 0 / 24 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sub-optimal Dosing | Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall) | GSAS Symptoms Score | 8.5 score on a scale | Standard Error 0.7 |
| Sub-optimal Dosing | Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall) | GSAS Frequency Score | 2.2 score on a scale | Standard Error 0.3 |
| Sub-optimal Dosing | Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall) | GSAS Severity Score | 1.0 score on a scale | Standard Error 0.1 |
| Optimal Dosing | Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall) | GSAS Symptoms Score | 5.2 score on a scale | Standard Error 0.5 |
| Optimal Dosing | Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall) | GSAS Frequency Score | 1.0 score on a scale | Standard Error 0.2 |
| Optimal Dosing | Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall) | GSAS Severity Score | 0.6 score on a scale | Standard Error 0.1 |