NCT02623816

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2015

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

October 25, 2022

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

1.3 years

First QC Date

November 29, 2015

Results QC Date

November 28, 2018

Last Update Submit

October 23, 2022

Conditions

Heartburn

Outcome Measures

Primary Outcomes (1)

  • 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. .

    6 weeks

Study Arms (2)

Sub-optimal dosing

NO 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.

Optimal dosing

EXPERIMENTAL

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.

Drug: Optimal Dosing of Omeprazole

Interventions

Optimal Dosing of OmeprazoleDRUG

Omeprazole 20 mg

Also known as: omeprazole
Optimal dosing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth Medical System

Cleveland, Ohio, 44109, United States

Location

Related Publications (1)

  • 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.

    PMID: 30094626RESULT

MeSH Terms

Conditions

Heartburn

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

1. Single healthcare system 2. Symptom scoring questionnaire 3. Study did not assess gastric pH

Results Point of Contact

Title
Nisheet Waghray
Organization
MetroHealth Medical Center
nwaghray@metrohealth.org
2167785736

Study Officials

  • M. Michael Wolfe, MD

    MetroHealth Medical System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

November 29, 2015

First Posted

December 8, 2015

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 25, 2022

Results First Posted

October 25, 2022

Record last verified: 2022-10

Locations

US(1)