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Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers

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ClinicalTrials.gov Identifier: NCT00584675
Recruitment Status : Withdrawn (Funding was never received so no patients were enrolled.)
First Posted : January 2, 2008
Last Update Posted : June 19, 2015
Information provided by:
University of California, Davis

Brief Summary:
Involves a 24-hour pH probe study using the Dx-pH Measurement System on patients who do not have symptoms of laryngopharyngeal reflux or gastroesophageal reflux disease to establish normal values for the Dx-pH Measurement System.

Condition or disease Intervention/treatment
Gastroesophageal Reflux Disease Device: Dx-pH Measurement Probe

Detailed Description:
The specific aim of this study is to establish the normal range of values in an adult population with no symptoms of laryngopharyngeal reflux disease or gastroesophageal reflux disease using the Dx-pH Measurement System.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers
Study Start Date : February 2007
Estimated Primary Completion Date : January 2008
Estimated Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Intervention Details:
    Device: Dx-pH Measurement Probe
    Dx-pH Measurement Probe measures gaseous pH values in the nasopharynx and oropharynx over a period of 24 hours.

Primary Outcome Measures :
  1. To develop a range of normal values in adults without symptoms of laryngopharyngeal reflux. [ Time Frame: At completion of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 18 years of age or older
  • no symptoms of laryngopharyngeal reflux or gastroesophageal reflux disease
  • score less than 10 on Reflux Symptom Index

Exclusion Criteria:

  • age less than 18
  • known lidocaine allergy
  • history of heartburn, regurgitation, chronic cough, voice changes, globus pharyngeus, excessive throat clearing, or swallowing problems
  • score 10 or greater on Reflux Symptom Index
  • current or past antacid use or other antireflux therapy
  • history of antireflux surgery
  • pregnancy
  • current anticoagulation therapy (warfarin, heparin, aspirin, clopidogrel bisulfate)
  • special/vulnerable populations (children, mentally handicapped, pregnant women, fetuses, prisoners, cognitive impairment, life-threatening disease, social or economic disadvantage)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584675

United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Principal Investigator: Peter Belafsky, MD, PhD University of California, Davis

Responsible Party: Peter Belafsky, MD, Ph.D., University of California Davis
ClinicalTrials.gov Identifier: NCT00584675     History of Changes
Other Study ID Numbers: 200714988-1
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Keywords provided by University of California, Davis:
laryngopharyngeal reflux disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases