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Dexlansoprazole to Treat Laryngopharyngeal Reflux and Lingual Tonsil Hypertrophy

NCT01328652 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-04-05

No results posted yet for this study

Summary

Main Hypothesis: The investigators hypothesize that measurements of lingual tonsil tissue (LTT) thickness will decrease following treatment with once daily oral dexlansoprazole 60 mg in patients diagnosed with laryngopharyngeal reflux (LPR) and lingual tonsil hypertrophy (LTH) compared to matched controls receiving placebo.

Primary endpoints include:

* 24-hour oropharyngeal pH testing, pre- and post-treatment
* Mean lingual tonsil tissue (LTT) thickness, pre- and post-treatment, as determined by CT scan of the base of tongue

Secondary endpoints include:

* Reflux Finding Score (RFS) on pre- and post-treatment endoscopy of the oropharynx
* Subjective outcome metrics for assessing LPR-related symptoms and associated quality of life
* Calgary Sleep Apnea Quality of Life Index
* Bed-partner assessment of snoring intensity according to a Visual Analog Scale
* Epworth Sleepiness Scale (ESS)
* Reflux Symptom Index (RSI)

Specific Aims: The primary objective of this study is to determine whether treatment of patients diagnosed with LPR and LTH with 3 months of PPI therapy reduces LTT thickness, as measured on CT scan of the tongue base.

The secondary objectives of this study are to:

* Evaluate changes in LPR-related symptoms and quality of life after therapy using the following subjective outcome metrics:

* Calgary Sleep Apnea Quality of Life Index
* Bed-partner assessment of snoring intensity according to a Visual Analog Scale
* Epworth Sleepiness Scale
* Reflux symptom index
* Correlate changes in LTT thickness with the following secondary endpoints:

* Changes in the above subjective outcome metrics
* Changes in endoscopic findings of LPR
* Changes in 24-hour oropharyngeal pH study results

Conditions

  • Laryngopharyngeal Reflux
  • Hypertrophy of Lingual Tonsil

Interventions

DRUG

dexlansoprazole

dexlansoprazole 60 mg once daily for 3 months

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Advanced Center for Specialty Care

    lead OTHER

Principal Investigators

  • Michael Friedman, MD · Head and Neck and Cosmetic Surgery Inc and Advanced Center for Specialty Care

  • Ninos J Joseph, BS · Advanced Center for Specialty Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-08-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01328652 on ClinicalTrials.gov