- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01450748
Efficacy and Safety of Alginos Oral Suspension to Treat Laryngopharyngeal Reflux
June 3, 2015 updated by: TTY Biopharm
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 104
- TTY Biopharm Company Limited Taipei Branch
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sodium alginate
oral suspension, 50 mg/ml
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oral suspension, 50 mg/ml, 20 ml three times daily, 8 weeks
Other Names:
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Placebo Comparator: Placebo
oral suspension without active ingredient
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matching placebo oral suspension, 50 mg/ml, 20 ml three times daily, 8 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean reduction in the total reflux symptom index (RSI) score from baseline to Week 8
Time Frame: before and after 8 weeks treatment
|
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
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before and after 8 weeks treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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before and after 1 day and 4 weeks treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tzu-Yu Hsiao, Ph.D., Department of Ear, Nose and Throat, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
October 7, 2011
First Submitted That Met QC Criteria
October 11, 2011
First Posted (Estimate)
October 12, 2011
Study Record Updates
Last Update Posted (Estimate)
June 8, 2015
Last Update Submitted That Met QC Criteria
June 3, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TTYALG1101
- NTUH-IRB-201106058MA (Other Identifier: TTY)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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