MedTrace Logo

Efficacy and Safety of Alginos Oral Suspension to Treat Laryngopharyngeal Reflux

NCT01450748 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-06-08

No results posted yet for this study

Summary

Laryngopharyngeal reflux (LPR), the backflow of gastric acid into the larynx and hypopharynx, is a contributing factor to hoarseness, throat clearing, throat pain, and globus sensation. The therapeutic effect of proton pump inhibitors (PPIs) is controversial because a high placebo effect can be observed. Sodium Alginate is an effective medication indicated for symptomatic treatment of gastroesophageal reflux. This randomized, double-blind, placebo-controlled study aims to evaluate the efficacy and safety profile of sodium alginates oral suspension (50 mg/ml) 20 ml 3 times daily for the treatment of with LPR patients in Taiwan. Efficacy assessments include mean reduction in the total reflux symptom index (RSI) score after 4 and 8 weeks treatment, mean reduction in the total reflux finding score (RFS) after 4 and 8 weeks treatment, mean changes in the total numbers of reflux episodes as measured by 24-hour ambulatory combined impedance-pH monitoring after 1 day and 8 weeks treatment. Safety assessments include incidence of adverse events. The study hypothesis is sodium alginate is superior over placebo in relieving LPR symptoms.

Conditions

  • Laryngopharyngeal Reflux

Interventions

DRUG

Sodium alginate

oral suspension, 50 mg/ml, 20 ml three times daily, 8 weeks

DRUG

Placebo

matching placebo oral suspension, 50 mg/ml, 20 ml three times daily, 8 weeks

Sponsors & Collaborators

  • TTY Biopharm

    lead INDUSTRY

Principal Investigators

  • Tzu-Yu Hsiao, Ph.D. · Department of Ear, Nose and Throat, National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01450748 on ClinicalTrials.gov