Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers

June 18, 2015 updated by: University of California, Davis

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.

Study Overview

Status

Withdrawn

Conditions

Gastroesophageal Reflux Disease

Intervention / Treatment

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

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Sacramento, California, United States, 95817
    - University of California Davis Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To develop a range of normal values in adults without symptoms of laryngopharyngeal reflux. Time Frame: At completion of study	At completion of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

Principal Investigator: Peter Belafsky, MD, PhD, University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Anticipated)

January 1, 2008

Study Completion (Anticipated)

February 1, 2008

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria