Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers

This study is currently recruiting participants.

Verified by University of California, Davis, June 2008

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00584675

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

MedlinePlus related topics: GERD

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment
Official Title:	Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers

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:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Contacts

Contact: Peter C Belafsky, MD, Ph.D.	916-734-4740	peter.belafsky@ucdmc.ucdavis.edu
Contact: Chitra Rao	916-734-6581	cgrao@ucdavis.edu

Locations

United States, California
University of California Davis Medical Center	Recruiting
Sacramento, California, United States, 95817
Contact: Peter Belafsky, MD, Ph.D. 916-734-4740 peter.belafsky@ucdmc.ucdavis.edu
Contact: Chitra Rao 916-734-6581 cgrao@ucdavis.edu
Principal Investigator: Peter C Belafsky, MD, Ph.D.

Sponsors and Collaborators

University of California, Davis

Investigators

Principal Investigator:

Peter Belafsky, MD, PhD

University of California, Davis

More Information

Responsible Party:	University of California Davis ( Peter Belafsky, MD, Ph.D. )
Study ID Numbers:	200714988-1
Study First Received:	December 26, 2007
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00584675
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

GERD
laryngopharyngeal reflux disease

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder

Gastrointestinal Diseases
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on January 16, 2009