Efficacy and Safety of Alginos Oral Suspension to Treat Laryngopharyngeal Reflux
Condition: Laryngopharyngeal Reflux
MeSH terms: Gastroesophageal Reflux; Laryngopharyngeal Reflux
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Sodium alginate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral suspension, 50 mg/ml, 20 ml three times daily, 8 weeks; matching placebo oral suspension, 50 mg/ml, 20 ml three times daily, 8 weeks
Other intervention name(s): Alginos
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sodium alginate; laryngopharyngeal reflux; combined impedance-pH monitoring