Phase 4
Completed N=64
Symptom Control Satisfaction With Proton Pump Inhibitor Regimen
Heartburn
Source: ClinicalTrials.gov NCT02623816 ↗
Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcomePrimary: 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
◆ Published Evidence
Established
24citations · ~3 / year
Optimal Omeprazole Dosing and Symptom Control: A Randomized Controlled Trial (OSCAR Trial).
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.
Linked Publications
-
Optimal Omeprazole Dosing and Symptom Control: A Randomized Controlled Trial (OSCAR Trial).
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 | — |
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)
Data sourced from ClinicalTrials.gov (NCT02623816) and the linked publication. 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. Informational only — not medical advice.