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Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03619811
Recruitment Status : Completed
First Posted : August 8, 2018
Results First Posted : September 20, 2021
Last Update Posted : September 20, 2021
Sponsor:
Information provided by (Responsible Party):
Rena Yadlapati, University of California, San Diego

Study Description
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Brief Summary:
This study plans to learn more about reflux associated laryngeal symptoms, and more efficient ways to diagnose and treat this condition.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Laryngopharyngeal Reflux Diagnostic Test: Reflux Band® Upper Esophageal Sphincter (UES) Assist Device Not Applicable

Detailed Description:
Reflux associated laryngeal symptoms, coined "laryngopharyngeal reflux", occurs when gastro-esophago-pharyngeal reflux contributes to chronic laryngeal symptoms such as throat clearing, sore throat and dysphonia. Over the past 25 years, Reflux associated laryngeal symptoms has been increasingly, and often incorrectly, diagnosed and has emerged as a point of controversy and confusion.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease
Actual Study Start Date : July 13, 2018
Actual Primary Completion Date : June 30, 2021
Actual Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Arm Intervention/treatment
Experimental: Symptomatic
This study examines the efficacy of the upper esophageal sphincter assist device as an adjunct to Proton-pump inhibitors (PPI) therapy in symptomatic subjects. (Reflux Band® Upper Esophageal Sphincter (UES) Assist Device)
 Diagnostic Test: Reflux Band® Upper Esophageal Sphincter (UES) Assist Device
UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms.


Outcome Measures
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Primary Outcome Measures :
  1. Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score [ Time Frame: Week 8 (Completion) ]
    Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms.

  2. Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score [ Time Frame: Week 4 ]
    Response will be assessed binary as positive or negative where a positive response is defined by a post-treatment reflux symptom index (RSI) score ≤ 13 and a 33% change from comparator RSI. The minimum value is 0 and the maximum value is 45. The lower the score means less reported symptoms and the higher the score means more reported symptoms.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-89 years male and female,
  • >8 weeks of symptoms of sore throat, throat clearing, and/or voice hoarseness,
  • naïve to PPI or able to stop for 8 weeks

Exclusion Criteria:

  • Laryngeal mass lesion on laryngoscopy;
  • Pregnant;
  • Unable to consent in English;
  • Imprisoned;
  • PPI intolerance;

  • Contraindication to UESAD use per manufacturer guidelines which include:

    • Patients with implants or implant parts that reside in the area where UESAD is applied.
    • Patients with an implanted pacemaker, implanted cardioverter defibrillator (ICD), vagus nerve stimulator, or other such similar devices implanted in the neck.
    • Patients diagnosed with glaucoma.
    • Patients who had a malignancy of the neck, including neck surgery.
    • Patients that may have an altered mental status including due to the use of sedative drugs or narcotics.
    • Patients with carotid artery disease, thyroid disease, a history of cerebrovascular disease, or any disorder of connective tissues (e.g., Marfan's Syndrome or Ehlers-Danlos Syndrome).
    • Patients who use nocturnal NIV machines such as CPAP or BiPAP.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619811


Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Rena Yadlapati, M.D. University of California, San Diego
  Study Documents (Full-Text)

Documents provided by Rena Yadlapati, University of California, San Diego:
Study Protocol and Statistical Analysis Plan  [PDF] September 30, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rena Yadlapati, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03619811    
Other Study ID Numbers: 18-0205
First Posted: August 8, 2018    Key Record Dates
Results First Posted: September 20, 2021
Last Update Posted: September 20, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Rena Yadlapati, University of California, San Diego:
esophageal disorders
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Laryngopharyngeal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Laryngeal Diseases
Respiratory Tract Diseases