Status:
UNKNOWN
Predictive Value of Subjective and Objective Measurement Tools for Extraesophageal Reflux
Lead Sponsor:
Respiratory Technology Corporation
Conditions:
Laryngopharyngeal Reflux
Eligibility:
All Genders
18-75 years
Brief Summary
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 tha...
Eligibility Criteria
Inclusion
- Presenting to the ENT clinic for distressing symptoms of hoarseness, laryngitis, and/or recurrent throat clearing for at least 3 months duration. Determined not to be caused by another factor, such as allergies or poor vocal hygiene.
- Laryngoscopic examination performed on day of enrollment
- Indications present for a 24 hour oropharyngeal pH study (Restech)
- Indication to begin a 3 month course of antireflux therapy (Figure 1) based on symptom presentation and widely accepted otolaryngologic findings
- Willing to return to clinic in 3 months for follow up pH study
- Willing to participate in weekly phone calls with the study investigator to discuss compliance with medication and lifestyle modifications.
Exclusion
- Expected non-compliance with the equipment and/or instructions (according the protocol) given by the investigator.
- Any subjects with significant medical conditions that, in the investigator's judgment, would compromise the subject's health and safety.
- Subjects who have undergone previous antireflux surgery
- Subjects treated for reflux, either with Proton Pump Inhibitors (PPI's) or H2RAs in the past 4 weeks
- Subjects previously treated for reflux, either with antireflux medication or surgery
- Subjects with alternative work schedules affecting nighttime sleep periods (i.e. nighttime shift employees)
- Subjects with conditions that contraindicate use of PPIs, as listed on product labeling.
- Women who are pregnant, or nursing.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01829074
Start Date
April 1 2013
End Date
December 1 2013
Last Update
April 11 2013
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