Efficacy and Safety of Alginos Oral Suspension to Treat Laryngopharyngeal Reflux

About this trial

Last updated 11 years ago

Study ID

TTYALG1101

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

12 to 75 Years

All Sexes

Trial Timing

Ended 11 years ago

What is this trial about?

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.

What are the participation requirements?

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