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Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers

This study has been withdrawn prior to enrollment.
(Funding was never received so no patients were enrolled.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00584675
First Posted: January 2, 2008
Last Update Posted: June 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of California, Davis
  Purpose
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 Intervention
Gastroesophageal Reflux Disease Device: Dx-pH Measurement Probe

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

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

Enrollment: 0
Study Start Date: February 2007
Estimated Study Completion Date: February 2008
Estimated Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
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.
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.
  Eligibility

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
Criteria

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)
  Contacts and Locations
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


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

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 Submitted: December 26, 2007
First Posted: January 2, 2008
Last Update Posted: June 19, 2015
Last Verified: June 2015

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

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