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Symptom Control Satisfaction With Proton Pump Inhibitor Regimen

Primary Purpose

Heartburn

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Optimal Dosing of Omeprazole
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heartburn

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • MetroHealth Medical System

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Sub-optimal dosing

Optimal dosing

Arm 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.

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.

Outcomes

Primary Outcome Measures

Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall)
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. .

Secondary Outcome Measures

Full Information

First Posted
November 29, 2015
Last Updated
October 23, 2022
Sponsor
MetroHealth Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02623816
Brief Title
Symptom Control Satisfaction With Proton Pump Inhibitor Regimen
Official Title
Prospective Study Assessing Patient Satisfaction of Symptom Control With Proton Pump Inhibitor Dosing Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heartburn

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sub-optimal dosing
Arm Type
No Intervention
Arm 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.
Arm Title
Optimal dosing
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Optimal Dosing of Omeprazole
Other Intervention Name(s)
omeprazole
Intervention Description
Omeprazole 20 mg
Primary Outcome Measure Information:
Title
Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall)
Description
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. .
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Michael Wolfe, MD
Organizational Affiliation
MetroHealth Medical System
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth Medical System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30094626
Citation
Waghray A, Waghray N, Perzynski AT, Votruba M, Wolfe MM. Optimal Omeprazole Dosing and Symptom Control: A Randomized Controlled Trial (OSCAR Trial). Dig Dis Sci. 2019 Jan;64(1):158-166. doi: 10.1007/s10620-018-5235-9. Epub 2018 Aug 9.
Results Reference
result

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Symptom Control Satisfaction With Proton Pump Inhibitor Regimen

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