Phase 4 N=64 Randomized Treatment

Symptom Control Satisfaction With Proton Pump Inhibitor Regimen

Heartburn

Bottom Line

View on ClinicalTrials.gov: NCT02623816 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2022

Primary outcome: Primary: Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall) — 8.5; 5.2; 2.2; 1.0 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Optimal Dosing of Omeprazole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: MetroHealth Medical Center
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall)	8.5; 5.2; 2.2; 1.0; 1.0; 0.6	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02623816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.