Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00584675
• Other study ID #: 200714988-1
• Status: Withdrawn
• Phase: N/A
• First received: December 26, 2007
• Last updated: June 18, 2015
• Start date: February 2007
• Est. completion date: February 2008

Study information

• Verified date: June 2015
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

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

Locations

Country	Name	City	State
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To develop a range of normal values in adults without symptoms of laryngopharyngeal reflux.		At completion of study	No