Positive Predictive Value of the Dx-pH Probe for Predicting PPI Response in LPR
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|ClinicalTrials.gov Identifier: NCT01755221|
Recruitment Status : Unknown
Verified December 2014 by Bruce Tan, Northwestern University.
Recruitment status was: Active, not recruiting
First Posted : December 24, 2012
Last Update Posted : December 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Laryngopharyngeal Reflux (LPR) Extraesophageal Reflux Reflux Laryngitis Posterior Laryngitis||Other: Single-center prospective evaluation of the Restech pH probe||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Evaluation of the Utility, Optimal Cutoff and Positive Predictive Value of a Pharyngeal pH Probe for Predicting Proton Pump Inhibitor Response in Treatment Naive Laryngopharyngeal Reflux|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||December 2015|
Single-center prospective evaluation of the Restech pH probe
Other: Single-center prospective evaluation of the Restech pH probe
All subjects will have a pH probe placed at their initial clinic visit and will have the probe removed 24 hours later. They will start on PPI medication (as per the standard of care) after probe removal. Subjects will have a follow up clinic visit 8-12 weeks after the initial visit. At the follow up visit, all subjects will have the option of a second probe placement to assess the effects of PPI therapy on reflux events.
- RSI Score [ Time Frame: 8-12 weeks after initial clinic visit ]Change from baseline in RSI score at 8-12 weeks after initial clinic visit/initiation of treatment will be used to define a response to PPI therapy
- Global improvement in self-reported symptoms [ Time Frame: 8-12 weeks after initial clinic visit ]Change from baseline in global improvement in self-reported symptoms at 8-12 weeks after initial clinic visit/initiation of treatment will be used to define response to PPI therapy
- Differences in pH between PPI responders and non-responders [ Time Frame: 8-12 weeks after initial clinic visit ]The Ryan score, total time (as a percent) and number of events below a pH of 4, 5, 6, and 7 will be compared between PPI responders and non-responders.
- Effects of PPI therapy on reflux events [ Time Frame: 8-12 weeks after initial clinic visit ]All subjects will have the option of a second pH probe placement at the follow up clinic visit 8-12 weeks after the initial clinic visit to assess the effects of PPI therapy on reflux events.
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): NCT01755221
|United States, Illinois|
|Northwestern Medical Faculty Foundation (NMFF) Sinus and Allergy Center|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Bruce Tan, MD||Northwestern University|