NCT01450748

Efficacy and Safety of Alginos Oral Suspension to Treat Laryngopharyngeal Reflux

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Alginos Oral Suspension (Sodium Alginate 50 mg/ml) for the Treatment of Patients With Laryngopharyngeal Reflux (LPR)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: TTY Biopharm · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This double-blind, randomized, placebo-controlled trial aims to evaluate the efficacy and safety profiles of sodium alginate oral suspension (50mg/ml) 20ml 3 times daily for the treatment of patients with laryngopharyngeal reflux (LPR) in Taiwan. Patients will be enrolled into study if they are at the age of 12 to 75 years old, have at least one symptom consistent with LPR and lasting for more than 4 weeks before study, with a total reflux symptom index (RSI)\>10, with a total reflux finding score (RFS)\>5, and have signed the informed consent form. Patients will be excluded if they are diagnosed as erosive gastroesophageal reflux disease (GERD)as evidenced by upper GI endoscopy, viral or bacterial laryngitis, or occupational exposures causing laryngitis, laryngeal or hypopharyngeal cancer, esophageal or gastric cancer, with history of neck radiation therapy, with history of esophageal or gastric surgery, with active pulmonary infection (pneumonia, tuberculosis) as evidenced by chest X-ray, with endotracheal tube intubation within 2 months before entering study, or taking any alginate preparations within 2 days; H2-blocker, prokinetic agent or antacid within 7 days; or proton pump inhibitors (PPIs) within 14 days before screening. The primary efficacy endpoint is mean reduction in the total RSI from baseline to Week 8. The secondary efficacy endpoints are mean reduction in the total RSI from baseline to Day 2 and Week 4; mean reduction in the RFS from baseline to Week 4 and Week 8; mean change in the individual component of RSI from baseline to Day 2 , Week 4 and Week 8; mean change in the individual component of RFS from baseline to Week 4 and Week 8; and mean change in the total numbers of reflux episodes as measured by 24-hr ambulatory combined impedance-pH monitoring from baseline to day 2 and week 8. The safety endpoint is incidence of adverse events. The study hypothesis is that sodium alginate is superior over placebo in treating patients with LPR.

Conditions

• Laryngopharyngeal Reflux

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-10-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2011-10-12
• Last updated: 2015-06-08

Locations

1 site across 1 country: Taiwan