Symptom Control Satisfaction With Proton Pump Inhibitor Regimen

Phase 4

Completed

• Conditions: Heartburn
• Interventions: Drug: Optimal Dosing of Omeprazole

• Registration Number: NCT02623816
• Lead Sponsor: MetroHealth Medical Center

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-11-29
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-08
• Results First Submitted: 2018-11-28
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-23
• Last Update Submitted: 2022-10-23
• Results First Posted: 2022-10-25
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optimal dosing	Optimal Dosing of Omeprazole	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.

Primary Outcome Measures

Name	Time	Method
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.; .

Trial Locations

Locations (1)

MetroHealth Medical System; 🇺🇸 Cleveland, Ohio, United States