Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers

NCT ID: NCT00584675

Last Updated: 2015-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Dx-pH Measurement Probe

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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University of California Davis

Principal Investigators

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Peter Belafsky, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California Davis Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

Other Identifiers

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200714988-1

Identifier Type: -

Identifier Source: org_study_id

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