Symptom Control Satisfaction With Proton Pump Inhibitor Regimen

Heartburn Clinical Trial

Official title:

Prospective Study Assessing Patient Satisfaction of Symptom Control With Proton Pump Inhibitor Dosing Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623816
• Other study ID #: IRB13-00089
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2022
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Heartburn

Intervention

Drug:
• Optimal Dosing of Omeprazole
Omeprazole 20 mg

Locations

Country	Name	City	State
United States	MetroHealth Medical System	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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