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Which Supraesophageal Reflux Symptoms Reliably Respond to Proton-Pump-Inhibitor (PPI) Therapy
This study is currently recruiting participants.
Verified by Mayo Clinic, September 2005
Sponsors and Collaborators: Mayo Clinic
AstraZeneca
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00170001
  Purpose

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.


Condition Intervention
Gastroesophageal Reflux
Drug: esomeprazole magnesium

MedlinePlus related topics: GERD
Drug Information available for: Magnesium Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Which Supraesophageal Reflux Symptoms Reliably Respond to PPI Therapy: A Large Simple Trial

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • To determine which symptom(s) are predictive of SER based on a complete response to PPI therapy

Secondary Outcome Measures:
  • To determine which symptoms demonstrate partial response with PPI therapy
  • To determine which features of a patient's history are predictive of a positive response to PPI therapy
  • To determine which features of a patient's history are predictive of a lack of response to PPI therapy
  • To develop a scoring system for the Supraesophageal Reflux Questionnaire (SRQ) that would predict a diagnosis of SER

Estimated Enrollment: 500
Study Start Date: April 2005
Estimated Study Completion Date: March 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170001

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Melissa Westergren     507-538-1392     westergren.melissa@mayo.edu    
Principal Investigator: Yvonne Romero, MD            
Sponsors and Collaborators
Mayo Clinic
AstraZeneca
Investigators
Principal Investigator: Yvonne Romero, M.D. Mayo Clinic
  More Information

Study ID Numbers: 452-05, IRUSESOM0376
Study First Received: September 12, 2005
Last Updated: March 6, 2006
ClinicalTrials.gov Identifier: NCT00170001  
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
supraesophageal reflux
laryngopharyngeal symptoms
pharynx
esophagus

Study placed in the following topic categories:
Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Omeprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009