Dexlansoprazole to Treat Laryngopharyngeal Reflux and Lingual Tonsil Hypertrophy
Public ClinicalTrials.gov record NCT01328652. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled Study of Dexlansoprazole to Treat Laryngopharyngeal Reflux and Lingual Tonsil Hypertrophy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT01328652
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 80 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 59 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2011
- Primary completion
- Jul 31, 2012
- Completion
- Dec 31, 2012
- Last update posted
- Apr 4, 2011
2011 – 2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Advanced Center for Specialty Care | Chicago | Illinois | 60657 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01328652, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 4, 2011 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01328652 live on ClinicalTrials.gov.