UnknownPhase 4

Dexlansoprazole to Treat Laryngopharyngeal Reflux and Lingual Tonsil Hypertrophy

United States80 participantsStarted 2011-06

Plain-language 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

Who can participate

Age range

18 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of LPR and LTH confirmed by 24-hour pharyngeal pH monitoring and CT of the tongue base, respectively * Age \> 20 and \< 60 years * Failure (in the opinion of the patient and treating physician) of current treatment regimen and willingness (by the patient) to discontinue all concurrent therapies for LPR whether prescription, over-the-counter, or herbal, and to remain off of these treatments for the entire course of the study Exclusion Criteria: * Pregnancy or anticipated pregnancy (confirmation of non-pregnant status will be made by urine human chorionic gonadotropin level) * Lactation * History or diagnosis of moderate to severe hepatic disease (based on liver function testing performed at screening adjusted for age, gender, race, concomitant medications and comorbidities * Current or within the previous (12 mo) usage of a proton pump inhibitor * Concurrent use of any medications, which interact adversely with dexlansoprazole or other proton pump inhibitors (e.g., penicillins, digoxin, iron salts, azole antifungals, atazanavir, tacrolimus, clopidogrel, etc.) * Allergy or sensitivity to dexlansoprazole (or other proton pump inhibitor) or cimetidine (or other H2 blocker) * History of laryngeal and/or pharyngeal surgery * Preexisting voice or swallowing disorder not related to LPR * Smoking * Neoplastic or infectious processes that are systemic or localized to the head and neck region

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lingual Tonsil Size

Timeframe: 3 months

Trial details

NCT IDNCT01328652

SponsorAdvanced Center for Specialty Care

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-08

Contact for this trial

Michael Friedman, MD

312-236-3642 hednnek@aol.com

View on ClinicalTrials.gov More Laryngopharyngeal Reflux trials