Efficacy and Safety of Alginos Oral Suspension to Treat Laryngopharyngeal Reflux

Last updated: June 3, 2015
Sponsor: TTY Biopharm
Overall Status: Completed

Phase

3

Condition

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Heartburn (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01450748
TTYALG1101
NTUH-IRB-201106058MA
  • Ages 12-75
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Patients with at least one symptom consistent with LPR, including hoarseness, throatclearing, throat pain, globus sensation in the throat, or chronic cough ≧ 4 weeksbefore 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 laryngoscopicexamination by investigators)

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

Exclusion

Exclusion Criteria:

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

  • Patients with erosive GERD as evidenced by upper GI endoscopy

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

  • Patients with history of uncontrolled hypertension or moderate to severe renalimpairment

  • Patients with history of esophageal or gastric surgery

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

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

  • Patients had taken any alginate preparations within 2 days; H2-blocker, prokineticagent or antacid within 7 days; or proton pump inhibitors (PPIs) within 14 days beforescreening

  • 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 enteringthe study

  • Patients with any other conditions or diseases that investigator considers it is notappropriate to enter the study

Study Design

Total Participants: 80
Study Start date:
October 01, 2011
Estimated Completion Date:
March 31, 2015

Study 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.

Connect with a study center

  • TTY Biopharm Company Limited Taipei Branch

    Taipei, 104
    Taiwan

    Site Not Available

+−

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.