Efficacy and Safety of Alginos Oral Suspension to Treat Laryngopharyngeal Reflux

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by TTY Biopharm.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
TTY Biopharm
ClinicalTrials.gov Identifier:
NCT01450748
First received: October 7, 2011
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Laryngopharyngeal Reflux
Drug: Sodium alginate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by TTY Biopharm:

Primary Outcome Measures:
  • Mean reduction in the total reflux symptom index (RSI) score from baseline to Week 8 [ Time Frame: before and after 8 weeks treatment ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Mean reduction in the total reflux symptom index (RSI) score from baseline to Day 2 and Week 4 [ Time Frame: before and after 1 day and 4 weeks treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: October 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium alginate
oral suspension, 50 mg/ml
Drug: Sodium alginate
oral suspension, 50 mg/ml, 20 ml three times daily, 8 weeks
Other Name: Alginos
Placebo Comparator: Placebo
oral suspension without active ingredient
Drug: Placebo
matching placebo oral suspension, 50 mg/ml, 20 ml three times daily, 8 weeks

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.

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450748

Contacts
Contact: Johnny Chu, Ph.D. +886-2-25090464 ext 280 johnnychu@tty.com.tw
Contact: Wei-Chung Hsu, Ph.D. +886-2-23123456 ext 65215 hsuwc@ntu.edu.tw

Locations
Taiwan
TTY Biopharm Company Limited Taipei Branch Recruiting
Taipei, Taiwan, 104
Contact: Johnny Chu, Ph.D.    +886-2-2509-0464 ext 280    johnnychu@tty.com.tw   
Contact: Viviana Wang, Master    +886-2-2509-0464 ext 331    viviana@tty.com.tw   
Principal Investigator: Tzu-Yu Hsiao, Ph.D.         
Sponsors and Collaborators
TTY Biopharm
Investigators
Principal Investigator: Tzu-Yu Hsiao, Ph.D. Department of Ear, Nose and Throat, National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: TTY Biopharm
ClinicalTrials.gov Identifier: NCT01450748     History of Changes
Other Study ID Numbers: TTYALG1101, NTUH-IRB-201106058MA
Study First Received: October 7, 2011
Last Updated: May 16, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by TTY Biopharm:
sodium alginate
laryngopharyngeal reflux
combined impedance-pH monitoring

Additional relevant MeSH terms:
Gastroesophageal Reflux
Regurgitation, Gastric
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Alginic acid
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014