drugset / Trial / NCT02530879

Comparison of Voice Therapy and Antireflex Therapy in LPR

NCT02530879

Phase 4 Withdrawn Temple University
RandomizedFactorialOpen-labelTreatment

Summary

This study will be a prospective, randomized, unblinded but controlled trial. Patients presenting to the Otolaryngology clinic who are diagnosed with laryngopharyngeal reflux disorder related dysphonia and meet inclusion criteria will be eligible to enroll in the study. Subjects will be randomized to one of three treatment arms, voice therapy, anti-reflux therapy, or a combination of voice therapy and anti-reflux therapy. Reflux symptom index (RSI) scores, reflux finding scores (RFS), voice handicap index-10 (VHI-10) scores, and consensus auditory perceptual evaluation-voice (CAPE-V) scores will be compared prior to initiation of therapy as well as at 1, 2, and 3 months following initiation of treatment.

Timeline

Start
2016-05
Primary completion
2017-08
Completion
2018-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Esomeprazole Small molecule 20 mg Oral
Comparator Esomeprazole Small molecule 40 mg Oral
Comparator Lansoprazole Other / unclassified 15 mg
Comparator Lansoprazole Other / unclassified 30 mg
Comparator Omeprazole Other / unclassified 20 mg Oral
Comparator Omeprazole Other / unclassified 40 mg Oral
Comparator Rantidine Unknown 150 mg
Comparator Rantidine Unknown 300 mg