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Proton Pump Inhibitor

Optimal Dosing of Omeprazole for Heartburn

Phase 4
Waitlist Available
Led By M. Michael Wolfe, MD
Research Sponsored by MetroHealth Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 10 weeks
Awards & highlights

Study Summary

This trial is testing whether patients with GERD who are not responding well to a lower dose of omeprazole will have their symptoms improve when they switch to taking omeprazole before their first meal of the day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall)
Secondary outcome measures
Symptom frequency and severity/distress scores from GSAS (Gastrointestinal distress)
Fetal Distress
Fetal Distress

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Optimal dosingExperimental Treatment1 Intervention
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 II: Sub-optimal dosingActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omeprazole
FDA approved

Find a Location

Who is running the clinical trial?

MetroHealth Medical CenterLead Sponsor
114 Previous Clinical Trials
21,325 Total Patients Enrolled
M. Michael Wolfe, MDPrincipal InvestigatorMetroHealth Medical System

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Digestive Diseases and SciencesJournal
Optimal Omeprazole Dosing and Symptom Control: A Randomized Controlled Trial (OSCAR Trial)
Waghray, Abhijeet, Nisheet Waghray, Adam T. Perzynski, Mark Votruba, and M. Michael Wolfe. 2018. “Optimal Omeprazole Dosing and Symptom Control: A Randomized Controlled Trial (OSCAR Trial)”. Digestive Diseases and Sciences. Springer Science and Business Media LLC. doi:10.1007/s10620-018-5235-9.
clinicaltrials.govStudy
Symptom Control Satisfaction With Proton Pump Inhibitor Regimen
Nisheet Waghray 2014. "Symptom Control Satisfaction With Proton Pump Inhibitor Regimen". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02623816.
~6 spots leftby Apr 2025
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