Efficacy and Safety of Alginos Oral Suspension to Treat Laryngopharyngeal Reflux

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TTY Biopharm
• Treatments: Alginic acid

Criteria

Inclusion Criteria:

• Patients with age of 12-75 years old (inclusive)

• Patients with at least one symptom consistent with LPR, including hoarseness, throat clearing, throat pain, globus sensation in the throat, or chronic cough ≧ 4 weeks before entering study

• Patients with a total reflux symptom index (RSI) >10 (based on a self-administered 9-item questionnaire of voice/throat complaints)

• Patients with a total reflux finding score (RFS) >5 (based on a laryngoscopic examination by investigators)

• Patients or their legal representatives have signed the informed consent form

Exclusion Criteria:

• Patients with viral or bacterial laryngitis, or occupational exposures causing laryngitis

• Patients with erosive GERD as evidenced by upper GI endoscopy

• Patients with laryngeal or hypopharyngeal cancer, esophageal or gastric cancer, , or with history of neck radiation therapy

• Patients with history of uncontrolled hypertension or moderate to severe renal impairment

• Patients with history of esophageal or gastric surgery

• Patients with active pulmonary infection (pneumonia, tuberculosis) as evidenced by chest X-ray

• Patients with endotracheal tube intubation within 2 months before entering study

• Patients had taken 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

• Patients with a history of allergy to the study drugs or their related compounds

• Patients with a history of alcohol or drug abuse, or with any psychiatric disease

• Patients participated any investigational drug trial within 4 weeks before entering the study

• Patients with any other conditions or diseases that investigator considers it is not appropriate to enter the study