← Back to Search

Proton Pump Inhibitor

Proton Pump Inhibitor for Enlarged Lingual Tonsils

Phase 4
Waitlist Available
Led By Michael Friedman, MD
Research Sponsored by Advanced Center for Specialty Care
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2 and 3 months
Awards & highlights

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

Eligible Conditions
  • Enlarged Lingual Tonsils
  • Laryngopharyngeal Reflux

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2 and 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2 and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lingual Tonsil Size
Secondary outcome measures
Calgary Sleep Apnea Quality of Life Index
Epworth Sleepiness scale
Laryngopharyngeal Reflux
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Proton Pump InhibitorExperimental Treatment1 Intervention
Treatment with dexlansoprazole 60 mg once daily for 3 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexlansoprazole
FDA approved

Find a Location

Who is running the clinical trial?

Advanced Center for Specialty CareLead Sponsor
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,178,182 Total Patients Enrolled
Michael Friedman, MDPrincipal InvestigatorHead and Neck and Cosmetic Surgery Inc and Advanced Center for Specialty Care

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Apr 2025