Symptom Control Satisfaction With Proton Pump Inhibitor Regimen

MetroHealth Medical Center

Status and phase: Completed; Phase 4

Conditions: Heartburn

Treatments: Drug: Optimal Dosing of Omeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02623816

IRB13-00089

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Sub-optimal dosing

No Intervention group

Description:

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.

Optimal dosing

Experimental group

Description:

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.

Treatment:

Drug: Optimal Dosing of Omeprazole