Symptom Control Satisfaction With Proton Pump Inhibitor Regimen

MetroHealth Medical Center64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heartburn

Interventions

Optimal Dosing of OmeprazoleDRUG

Omeprazole 20 mg

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

MetroHealth Medical System

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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