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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00170001
First received: September 12, 2005
Last updated: December 13, 2011
Last verified: December 2011
  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: Nexium
Drug: Sugar Pill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Which Supraesophageal Reflux Symptoms Reliably Respond to PPI Therapy: A Large Simple Trial

Resource links provided by NLM:


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 [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine which symptoms demonstrate partial response with PPI therapy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • To determine which features of a patient's history are predictive of a positive response to PPI therapy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • To determine which features of a patient's history are predictive of a lack of response to PPI therapy [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • To develop a scoring system for the Supraesophageal Reflux Questionnaire (SRQ) that would predict a diagnosis of SER [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 500
Study Start Date: April 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar pill Drug: Sugar Pill
40 mg BID
Active Comparator: Active Comparator Drug: Nexium
40 mg bid dosing

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170001

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
AstraZeneca
Investigators
Principal Investigator: Yvonne Romero, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Dr. Yvonne Romero, Mayo Clinic Rochester, MN
ClinicalTrials.gov Identifier: NCT00170001     History of Changes
Other Study ID Numbers: 452-05, IRUSESOM0376
Study First Received: September 12, 2005
Last Updated: December 13, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014