Symptom Control Satisfaction With Proton Pump Inhibitor Regimen

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Heartburn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Optimal dosing

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.

Group Type EXPERIMENTAL

Optimal Dosing of Omeprazole

Intervention Type DRUG

Omeprazole 20 mg

Interventions

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Optimal Dosing of Omeprazole

Omeprazole 20 mg

Intervention Type DRUG

Other Intervention Names

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omeprazole

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes