Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
5 participants
INTERVENTIONAL
2016-09-01
2018-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to use a standard approach to help patients stop taking PPIs by adopting lifestyle habits known to reduce the symptoms of GERD while they slowly reduce their PPI dose. All medications used for this study are approved by the U.S. Food and Drug Administration ("FDA"). You are being asked to take part in this study because you have been taking a PPI for longer than the recommended time, and have either a diagnosis of GERD, gastritis, or an unclear indication for being on a PPI. About 100 patients from the Mount Carmel St. Ann's Family Medicine practice will participate in this research.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PPI Versus Placebo in Severe Functional Heartburn
NCT00222989
Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD
NCT00362609
A Randomized Trial of Medical and Surgical Treatments for Patients With GERD Symptoms That Are Refractory to Proton Pump Inhibitors
NCT01265550
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
NCT00365300
Assessment of the Role of Tegaserod Therapy in the Management of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).
NCT00171483
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PPI Taper
PPI Taper using Lifestyle Modifications, per study protocol
Lifestyle Modifications
Lifestyle Modifications to wean off of a Proton Pump Inhibitor, i.e. avoiding dietary triggers, waiting 3 hours to lie flat, and elevating the head of the bed
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lifestyle Modifications
Lifestyle Modifications to wean off of a Proton Pump Inhibitor, i.e. avoiding dietary triggers, waiting 3 hours to lie flat, and elevating the head of the bed
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male or female
* PPI on home medication reconciliation
* GERD that is symptom controlled (per questionnaire), OR
* Gastritis that is symptom controlled (per questionnaire), OR
* An unclear indication for PPI use but free of GERD/gastritis/ulcer symptoms (includes patients on GI prophylaxis from the hospital and continued medication)
* Desire or willingness to be off of PPI chronically
* On PPI chronically (\> 2 months or 8 weeks, can be intermittent use)
* Initial PPI dose cannot exceed more than the equivalent of Omeprazole 40mg PO BID
* Comprehend English well (per provider's discretion; to understand questionnaires, instructions, etc.)
Exclusion Criteria
* Co-morbid diagnosis of Peptic Ulcer Disease, H.pylori infection, Barrett's esophagus, malignancy, Inflammatory Bowel Disease
* Diagnosis of moderate to severe renal impairment (defined as CrCl \<50 mL/min; reasoning due to caution of H2RB on renal failure)
* Diagnosis of prolonged QT interval with renal impairment (reasoning due to H2RB with concomitant renal failure may increase QT interval if not renally dosed)
* True allergy to Proton Pump Inhibitor and / or H2 Receptor Blocker
* Patients with frequent cardiac angina symptoms (decreasing the dose of PPI may cause rebound GERD and the patient may think they are having a heart attack)
* Pregnant women, fetuses, neonates or fetal material
* Females of reproductive potential at time of research that are not on a form on birth control (OCPs, tubal ligation, etc) or lactating
* Adults with decisional impairment
* Prisoners
* Patients with uncontrolled Psychological illness
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mount Carmel Health System
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Stephanie Meller
Family Medicine Physician / Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephanie O Meller, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Carmel Health System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mount Carmel St. Ann's Family Medicine Center
Westerville, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
160809-6
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.