Ignite Creation Date:
2024-05-06 @ 1:13 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01755221
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2012-12-18
Brief Title:
Positive Predictive Value of the Dx-pH Probe for Predicting PPI Response in LPR
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
A Prospective Evaluation of the Utility Optimal Cutoff and Positive Predictive Value of a Pharyngeal Potential of Hydrogen pH Probe for Predicting Proton Pump Inhibitor Response in Treatment Naive Laryngopharyngeal Reflux
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to better understand whether information obtained from a pH probe can help physicians predict whether a patient will respond to the medication that is prescribed for laryngopharyngeal reflux LPR The current treatment given to individuals who are diagnosed with LPR is a course of proton pump inhibitor PPI medication Subjects who agree to participate in this study will have a small flexible tube about the width of a piece of cooked spaghetti placed in their throat This tube measures the pH in the throat over a period of 24 hours and helps physicians study the relationship between pH level LPR symptoms and the effectiveness of PPI therapy This study may help physicians find out if certain symptoms or characteristics can help them predict if the PPI medication will be effective for each patient After probe removal subjects will receive compensation They will return to the clinic at their regularly scheduled follow-up visit with the physician 8 to 12 weeks after starting the PPI medication At that time subjects can choose to participate in an optional probe placement
Detailed Description:
The purpose of this research study is to better understand whether information obtained from a pH probe can help physicians predict whether a patient will respond to the medication that is prescribed for laryngopharyngeal reflux LPR The current treatment given to individuals who are diagnosed with LPR is a course of proton pump inhibitor PPI medication This medication reduces the amount of gastric acid that is produced and generally leads to symptom relief In order to study whether the pH probe can help physicians predict if the patient will respond to PPI therapy the physicians will measure the pH level of patients throats before they start PPI medication Subjects who agree to participate in this study will have a small flexible tube about the width of a piece of uncooked spaghetti placed in their throat The physician will place the tube through the nose until the tip is in the back of the throat high enough so that the patient will not feel it when they talk eat drink or swallow This tube measures the pH in the throat over a period of 24 hours and helps physicians study the relationship between pH level LPR symptoms and the effectiveness of PPI therapy This study may help physicians find out if certain symptoms or characteristics can help them predict if the PPI medication will be effective for each patient After probe removal subjects will receive compensation They will return to the clinic at their regularly scheduled follow-up visit with the physician 8 to 12 weeks after starting the PPI medication At that time subjects can choose to participate in an optional probe placement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None