Efficacy and Safety of Alginos Oral Suspension to Treat Laryngopharyngeal Reflux

NCT01450748 | Completed Phase 3 DMC

• 2 other identifiers: TTYALG1101NTUH-IRB-201106058MA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sodium alginate; laryngopharyngeal reflux; combined impedance-pH monitoring

Outcome Measures

Primary Outcomes (1)

• Mean reduction in the total reflux symptom index (RSI) score from baseline to Week 8

  RSI is a self-administered 9-item questionnaire. RSI can be completed in less than 1 minute. The scale for each individual item ranges from 0 (no problem) to 5 (severe problem), with a maximum total score of 45. A total RSI score of \>10 is suggestive of laryngopharyngeal reflux

  before and after 8 weeks treatment

Secondary Outcomes (1)

• Mean reduction in the total reflux symptom index (RSI) score from baseline to Day 2 and Week 4

  before and after 1 day and 4 weeks treatment

Study Arms (2)

Sodium alginate

EXPERIMENTAL

oral suspension, 50 mg/ml

Drug: Sodium alginate

Placebo

PLACEBO COMPARATOR

oral suspension without active ingredient

Drug: Placebo

Interventions

Sodium alginate DRUG

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

Also known as: Alginos

Sodium alginate

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TTY Biopharm: lead

Study Sites (1)

TTY Biopharm Company Limited Taipei Branch

Taipei, 104, Taiwan

Location

MeSH Terms

Conditions

Laryngopharyngeal Reflux

Interventions

Alginates

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Polysaccharides; Carbohydrates

Study Officials

• Tzu-Yu Hsiao, Ph.D.

  Department of Ear, Nose and Throat, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 12, 2011
• Study Start: October 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

TW (1)