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

Sponsor
MetroHealth Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02623816
Collaborator
(none)
150
Enrollment
1
Location
3
Arms

Study Details

Study Description

Brief Summary

The overall aim of this study is to assess if patients with persistent 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Optimal Dosing of Omeprazole
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Aug 1, 2014
Anticipated Primary Completion Date :
Jul 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sub-optimal/optimal dosing

Patients will not change sub-optimal dosing regimen of omeprazole 20 mg for 6 weeks after which they will receive optimal dosing of omeprazole for 4 weeks. Rescue antacid use is permitted. Total duration of 10 weeks.

Drug: Optimal Dosing of Omeprazole
Omeprazole 20 mg
Other Names:
  • omeprazole

    		•
    No Intervention: Sub-optimal dosing

    No change will be made to the sub-optimal dosing regimen of omeprazole 20 mg. Rescue antacid use is permitted. Total duration of 10 weeks.
    Experimental: Optimal dosing

    Patients will be administered optimal dosing 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
    Omeprazole 20 mg
    Other Names:
  • omeprazole

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Symptom frequency and severity/distress scores from GSAS (overall) [6 weeks]

    2. Symptom frequency and severity/distress scores from GSAS (overall) [10 weeks]

    Secondary Outcome Measures

    1. Symptom frequency and severity/distress scores from GSAS (Gastrointestinal distress) [6 weeks, 10 weeks]

    2. Symptom frequency and severity/distress scores from GSAS (Heartburn) [6 weeks, 10 weeks]

    3. Symptom frequency and severity/distress scores from GSAS (Upper respiratory symptoms) [6 weeks, 10 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MetroHealth Medical System Cleveland Ohio United States 44109

    Sponsors and Collaborators

    • MetroHealth Medical Center

    Investigators

    • Principal Investigator: M. Michael Wolfe, MD, MetroHealth Medical System

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    M. Michael Wolfe, Chairman of Internal Medicine, MetroHealth Medical Center
    ClinicalTrials.gov Identifier:
    NCT02623816
    Other Study ID Numbers:
    • 13-00089
    First Posted:
    Dec 8, 2015
    Last Update Posted:
    Dec 8, 2015
    Last Verified:
    Dec 1, 2015
    Additional relevant MeSH terms:
    Heartburn
    Omeprazole

    Study Results

    No Results Posted as of Dec 8, 2015