RecruitingPhase 4ACTRN12614000114640

Clinical Evaluation of Malvatricin in the Reduction of Microorganisms Associated to Oropharynx Infections

Malvatricin is Tested in Patients with Oropharynx Infections Compared to Placebo in order to Reduce the Microorganisms

Sponsor

Laboratorio Daudt Oliveira Ltda

Enrollment

90 participants

Start Date

Dec 1, 2013

Study Type

Interventional

Conditions

Pharyngitis Infection

Summary

The use of antiseptics for the treatment of oropharyngeal infections have been reported in the scientific literature, and many products have the efficacy assessed by clinical studies. Conditions of the oropharynx as pharyngitis and odinofagias, and oral cavity, such as periodontal disease, mouth ulcers, stomatitis, and its symptoms, can be attenuated with the use of products containing antiseptics, antibiotics and anesthetics. The adjunctive use of these products, followed by professional treatment, is a valuable tool in the treatment of these conditions, and randomized clinical trials, double-blind, and controlled with placebo should be used to prove the effectiveness of these products. The objective of this study is to evaluate the clinical efficacy of Malvatricin 'Registered Trademark' (Lab Daudt de Oliveira, RJ) in the reducing of microorganisms associated to oropharynx infections.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a throat and mouth antiseptic product called Malvatricin can reduce the number of bacteria in the throat and mouth in people who have a sore throat or painful swallowing (odynophagia). The study is being done in otolaryngology (ear, nose, and throat) clinics and will compare Malvatricin to a placebo (inactive treatment). You may be eligible if: - You are between 18 and 80 years of age - You have had a sore or painful throat for 48 hours or less - You have been assessed by a doctor at a participating ENT clinic You may NOT be eligible if: - You are pregnant - You have a malignant tumour (cancer) of the mouth or throat Talk to your doctor about whether this trial might be right for you.

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Interventions

Arm 1: The solution ready-to-use contains quinosol 1 mg/ml and tyrothricin 0,1 mg/ml. It is necessary to rinse 20 ml of the solution in the mouth for 60 seconds just a single time. Arm 2: The tablet

Arm 1: The solution ready-to-use contains quinosol 1 mg/ml and tyrothricin 0,1 mg/ml. It is necessary to rinse 20 ml of the solution in the mouth for 60 seconds just a single time. Arm 2: The tablet contains quinosol 0,7 mg/tablet, tyrothricin 1,0 mg/tablet and benzocaine 5,0 mg/tablet. It is necessary to dissolve one tablet in the mouth just a single time. Arm 3: The spray contains quinosol 2,0 mg/ml, tyrothricin 0,1 mg/ml and lidocaine chloride 4,0 mg/ml. It is necessary to perform 3 spray applications in the mouth in a single time. Each pharmaceutical form was compared to its respective placebo. No strategies were used to monitor adherence to the treatment because the intervention is realized in just one visit followed by sub-investigator/investigator.

Locations(1)

Rio de Janeiro, Brazil

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ACTRN12614000114640

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