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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This study has been withdrawn prior to enrollment.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:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584675
First received: December 26, 2007
Last updated: March 26, 2009
Last verified: March 2009
History of Changes
  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: Open Label
Official Title: Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Peter Belafsky, MD, Ph.D., University of California Davis
ClinicalTrials.gov Identifier: NCT00584675     History of Changes
Other Study ID Numbers: 200714988-1
Study First Received: December 26, 2007
Last Updated: March 26, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013