Evaluating Treatment Response in Laryngo-Pharyngeal Reflux

NCT01328392 | Withdrawn

• 1 other identifier: 39853
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Although laryno-pharyngeal reflux (LPR) and gastroesophageal reflux disease (GERD) differ in symptoms and treatment, they are diagnosed by the same standard 24-hour pH monitoring system which measures liquid reflux in the esophagus. The investigators are evaluating a new 24-hour pharyngeal pH monitoring system by Restech which can measure acid exposure in the airway and can be used specifically for LPR diagnosis. The purpose of this study is to determine whether the Restech device is more effective than standard pH monitoring in predicting the response to proton pump inhibitor (PPI) acid suppression therapy using Dexlansoprazole in patients with symptoms and/or manifestations of LPR.

Conditions

Laryngo-pharyngeal Reflux

Keywords

LPR; GERD

Outcome Measures

Primary Outcomes (1)

• Ability of Restech to predict LPR symptom improvement after treatment with Dexlansoprazole.

  Successful LPR symptom improvement will be defined as a 25% improvement in Reflux Symptom Index (RSI)after 3 months of Dexlansoprazole.

  3 months

Secondary Outcomes (5)

• Comparison between standard pH data and Restech data (normal vs.abnormal acid exposure, using established normative data values) before and after treatment with Dexlansoprazole.

  3 months

• Correlation between Restech acid exposure events and standard pH monitoring acid exposure events.

  3 months

• Laryngoscopic findings pre and post Dexlansoprazole treatment.

  3 months

• Differences between RSI and general GERD symptom questionnaire scores on and off Dexlansoprazole.

  3 months

• Correlation of RSI and general GERD symptom questionnaire scores with Restecha dn standard pH values.

  3 months

Interventions

Dexlansoprazole DRUG

30mg a day, 3 months

Also known as: Dexilant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years old or above
• Have a clinical diagnosis of LPR
• Able and willing to provide consent

You may not qualify if:

• History of any previous anti-reflux operation or procedure
• History of pharyngeal or laryngeal surgery
• History of larngeal or hypolaryngeal neoplasm
• Allergy or significant adverse reaction to PPI
• Patient on PPI therapy within 4 weeks prior to enrollment
• A cumulative history of PPI therapy equal to or greater than 3 months
• History of noncompliance with medication or study protocols
• Enrolled in another clinical trial using investigational medications

Sponsors & Collaborators

• University of Washington: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Dexlansoprazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Brant K Oelschlager, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 4, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 5, 2017

Record last verified: 2011-03

Locations

US (1)