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Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease (ADHERE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Vaezi, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00388453
First received: October 13, 2006
Last updated: May 24, 2017
Last verified: May 2017
Results First Received: March 10, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: GERD
Larynx Disease
Interventions: Device: Dx-pH Probe
Procedure: Manometry

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Volunteers for all three groups were recruited from the Vanderbilt Medical Center

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Healthy Volunteers With no History of GERD or EERD or PPI Use

Healthy volunteers with no history of GERD or EERD or PPI use

Dx-pH Probe: 24 hour ph monitoring

Manometry: procedure to measure LES and UES

Volunteers With History of Gastroesophageal Reflux Disease Patients with a history of GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and had an improvement of their symptoms with PPI use and if they had erosive esophagitis by Los Angeles classification at endoscopy.
Volunteers With Laryngopharangeal Reflux (LPR) Patients suspected to have reflux-related laryngeal symptoms, including chronic cough, throat clearing and hoarseness. This group included non-smokers with unremarkable chest radiographs who had undergone extensive testing and exclusion of other common causes for their laryngeal symptoms by the Vanderbilt Allergy, Sinus and Asthma Program (ASAP), and Vanderbilt Voice Center (spirometry, methacholine challenge, sputum eosinophil count, otolaryngology exam, high-resolution computerized tomography scan of the thorax and sinuses and sinus testing).

Participant Flow:   Overall Study
    Healthy Volunteers With no History of GERD or EERD or PPI Use   Volunteers With History of Gastroesophageal Reflux Disease   Volunteers With Laryngopharangeal Reflux (LPR)
STARTED   20   17   10 
COMPLETED   20   17   10 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Male and female normal volunteers who had no LPR symptoms or known history of GERD.

Reporting Groups
  Description
Healthy Volunteers With no History of GERD or EERD or PPI Use

Healthy volunteers with no history of GERD or EERD or PPI use

Dx-pH Probe: 24 hour ph monitoring

Manometry: procedure to measure LES and UES

Volunteers With Gastroesophageal Reflux Disaese (GERD) History of GERD symptoms (heartburn and/or regurgitation) at least once in a week in the past month and had an improvement of symptoms with PPI use and if they had erosive esophagitis by LA classification at endoscopy
Volunteers With Laryngopharangeal Reflux (LPR) Suspected to have reflux-related laryngeal symptoms, including chronic cough, throat clearing,and hoarseness.
Total Total of all reporting groups

Baseline Measures
   Healthy Volunteers With no History of GERD or EERD or PPI Use   Volunteers With Gastroesophageal Reflux Disaese (GERD)   Volunteers With Laryngopharangeal Reflux (LPR)   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   17   10   47 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      20 100.0%      17 100.0%      9  90.0%      46  97.9% 
>=65 years      0   0.0%      0   0.0%      1  10.0%      1   2.1% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      12  60.0%      11  64.7%      6  60.0%      29  61.7% 
Male      8  40.0%      6  35.3%      4  40.0%      18  38.3% 
Region of Enrollment 
[Units: Participants]
       
United States   20   17   10   47 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Decrease in pH From Baseline to <4   [ Time Frame: 24 hours ]

2.  Primary:   Decrease in pH From Baseline to <5   [ Time Frame: 24 hours ]

3.  Primary:   Decrease in pH From Baseline to <6   [ Time Frame: 24 hours ]

4.  Secondary:   Number of Reflux Events   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Lack of prior validation studies on appropriate positioning of the oropharyngeal pH probe.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michael Vaezi, MD, PhD
Organization: Vanderbilt University
phone: 615.322.3739
e-mail: michael.vaezi@vanderbilt.edu



Responsible Party: Michael Vaezi, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00388453     History of Changes
Other Study ID Numbers: 060860
Study First Received: October 13, 2006
Results First Received: March 10, 2016
Last Updated: May 24, 2017