Status:
COMPLETED
Efficacy and Safety of Alginos Oral Suspension to Treat Laryngopharyngeal Reflux
Lead Sponsor:
TTY Biopharm
Conditions:
Laryngopharyngeal Reflux
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
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 therapeuti...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01450748
Start Date
October 1 2011
End Date
March 1 2015
Last Update
June 8 2015
Active Locations (1)
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1
TTY Biopharm Company Limited Taipei Branch
Taipei, Taiwan, 104