Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers

NCT00584675 | Withdrawn

• 1 other identifier: 200714988-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD; laryngopharyngeal reflux disease

Outcome Measures

Primary Outcomes (1)

• To develop a range of normal values in adults without symptoms of laryngopharyngeal reflux.

  At completion of study

Interventions

Dx-pH Measurement Probe DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• no symptoms of laryngopharyngeal reflux or gastroesophageal reflux disease
• score less than 10 on Reflux Symptom Index

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Peter Belafsky, MD, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 2, 2008
• Study Start: February 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: February 1, 2008
• Last Updated: June 19, 2015

Record last verified: 2015-06

Locations

US (1)