Status:
COMPLETED
Which Supraesophageal Reflux Symptoms Reliably Respond to Proton-Pump-Inhibitor (PPI) Therapy
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
AstraZeneca
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators hypothesize that persons with the particular cluster of symptoms that are due to supraesophageal reflux (SER) will have complete resolution of those symptoms with adequate acid suppr...
Detailed Description
Estimates suggest that up to 50% of Voice Clinic patients and 10% of ENT and Pulmonology outpatients seek medical care for chronic laryngopharyngeal symptoms resulting from supraesophageal reflux (SER...
Eligibility Criteria
Inclusion
- Primary complaint includes one of the following symptoms: chronic cough (dry, hacking, or nocturnal), hoarseness, sore throat, globus sensation, or throat clearing. These symptoms will be identified by a yes response to SRQ (Appendix 7) items 2, 3, 4, 5, 6, and 8. Furthermore, symptom(s) must be chronic (present for at least 1 month), and recurrent (at least twice per week). These criteria correspond to SRQ columns on page 3-5. The first column asks: When in your life did you first notice this symptom? A response with either number 2, 3, 4, or 5 meets criteria for chronic. The second column asks: How frequently have you noticed the symptom? A response with either number 3, 4, or 5 meets criteria for recurrent.
Exclusion
- History of head and neck cancer/radiation/surgery (SRQ items 15, 16, 17)
- History of esophagus/stomach surgery (SRQ item 22)
- Peptic or duodenal ulcer disease; stomach or gastric ulcer disease; history of esophageal stricture, or Barrett's esophagus, or esophagitis, or tumor of the esophagus or stomach (SRQ item 23 and review of electronic surgical records of Mayo Clinic patients)
- Presence of alarm symptoms (hemoptysis, unexplained loss of 10 or more pounds in the past 3 months), obtained from Appendix 5 for Community Subjects, medical record for clinic subjects. History of dysphagia, defined as a yes answer to SRQ item 7.
- PPI use within 4 weeks, obtained from Appendix 5 for Community Subjects, medical record for clinic subjects
- Use of warfarin or digoxin, obtained from Appendix 5 for Community Subjects, medical record for clinic subjects
- Pregnancy at the time of enrollment, based on urine pregnancy test
- Inability to understand or read English at a 6th grade level
- Residence outside of the United States of America (USA)
- Age younger than 18 years old
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00170001
Start Date
April 1 2005
End Date
August 1 2006
Last Update
December 15 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905