Which Supraesophageal Reflux Symptoms Reliably Respond to Proton-Pump-Inhibitor (PPI) Therapy

Completed · Not applicable

Conditions studied: Gastroesophageal Reflux

In brief

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 suppression when a PPI is administered for 6 months.

Key facts

Study ID

NCT00170001

Run by

Mayo Clinic

People needed

500

Starts

2005-04-01

Expected to finish

2006-08-01

Last updated by the study team

2011-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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