Symptom Control Satisfaction With Proton Pump Inhibitor Regimen

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.

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Key information

Conditions

Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

MetroHealth Medical System

Cleveland, Ohio, 44109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Optimal Dosing of Omeprazole

Drug

Omeprazole 20 mg

Other names: omeprazole

Primary outcomes

Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall)

Time frame: 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.

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Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Registry information

Official study title

Prospective Study Assessing Patient Satisfaction of Symptom Control With Proton Pump Inhibitor Dosing Regimen

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Dec 8, 2015
Registry last updated: Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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