Gastroesophageal Reflux Clinical Trial
Official title:
Precision Approach to PPI Therapy in Gastroesophageal Reflux Disease
NCT number | NCT03619811 |
Other study ID # | 18-0205 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 13, 2018 |
Est. completion date | June 30, 2021 |
Verified date | August 2021 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study plans to learn more about reflux associated laryngeal symptoms, and more efficient ways to diagnose and treat this condition.
Status | Completed |
Enrollment | 43 |
Est. completion date | June 30, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego | La Jolla | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score | 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. | Week 8 (Completion) | |
Primary | Patient-reported Symptom Response to Treatment Measured by the Reflux Symptom Index (RSI) Score | 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. | Week 4 |
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