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More info
You can access this
clinical trial
if you have
Laryngopharyngeal Reflux or Hypertrophy of Lingual Tonsil
and you are
between 18 and 59
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

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

Provided treatments

  • Drug: dexlansoprazole

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01328652. The sponsor of the trial is Advanced Center for Specialty Care and it is looking for 80 volunteers for the current phase.
Official trial title:
A Randomized, Double-blind, Placebo-controlled Study of Dexlansoprazole to Treat Laryngopharyngeal Reflux and Lingual Tonsil Hypertrophy