Predictive Value of Subjective and Objective Measurement Tools for Extraesophageal Reflux
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|ClinicalTrials.gov Identifier: NCT01829074|
Recruitment Status : Unknown
Verified April 2013 by Respiratory Technology Corporation.
Recruitment status was: Enrolling by invitation
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
Acid reflux can cause many symptoms in the throat, including discomfort or pain, and difficulty with breathing and voice problems. Doctors have different ways of diagnosing and treating the reflux that causes these symptoms, and they are trying to better understand what the best ways are to treat the patients with these symptoms.
Usually, a doctor will prescribe medication for reflux based on the symptoms a patient complains of. Sometimes it works and the patient gets better, sometimes it does not work and the patient's condition does not improve. The doctor will also use findings from an examination with an endoscope in the patient's throat to see if there is any damage that might have been caused by reflux. One new device that doctors use to help them diagnose reflux has a sensor on the end of a tube that goes through the nose and rests in the throat. This sensor measures the acid reflux for 24 hours, showing the doctor when acid reflux occurs.
The study doctors are performing this research study to help them understand more about acid reflux disease, and the best ways to diagnose and treat their patients who have acid reflux.
The study involves procedures, medications and devices that are already used regularly in doctors' offices and hospitals. The experimental part of this research is blinding the study doctor to the results of the pH study until the end of a three month course of antireflux medication, and performing a second pH study to measure change in acid exposure.
Hypothesis: The Restech pH study helps identify patients who will respond positively to acid inhibitory therapy, and patients whose study normalizes will have better Symptomatic response rates than those whose pH levels fail to normalize.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||December 2013|
- Symptomatic Improvement (treatment result) in the group of patients who are "LPR negative" (normal pH study) at baseline versus the symptomatic improvement of the patients who are "LPR positive" (abnormal pH study) at baseline. [ Time Frame: 12/2013 (up to 8 months) ]
After their first set of visits, the patients will be followed during their 3 month course of anti-reflux medications (PPIs). After three months, the patients will be asked to repeat the VAS and validated symptoms questionnaires. These will be compared to their baseline scores to measure symptomatic improvement.
Using the criterion of 50% improvement in symptoms as the cutoff point (dividing factor), the two populations will be divided further into two groups: responders and non-responders.
The amount of responders in each group will be compared to see if there is a greater proportion of responders in the group of patients who were LPR positive at baseline than in the group who were LPR negative at baseline.
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): NCT01829074
|Principal Investigator:||Nimish Vakil, MD||University of Wisconsin, Madison, USA|