Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000114640
Ethics application status
Approved
Date submitted
8/01/2014
Date registered
29/01/2014
Date last updated
29/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Evaluation of Malvatricin in the Reduction of Microorganisms Associated to Oropharynx Infections
Scientific title
Malvatricin is Tested in Patients with Oropharynx Infections Compared to Placebo in order to Reduce the Microorganisms
Secondary ID [1] 283859 0
None
Universal Trial Number (UTN)
U1111-1151-7907
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharyngitis 290840 0
Infection 290903 0
Condition category
Condition code
Respiratory 291204 291204 0 0
Other respiratory disorders / diseases
Infection 291255 291255 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288537 0
Treatment: Drugs
Comparator / control treatment
The solution placebo is mainly composed of ethyl alcohol, glycerol, menthol and water. The tablet placebo is mainly composed of silicon dioxide. The spray placebo is mainly composed of ethyl alcohol, mint oil and sorbitol. All of these types are used in the same dose, duration, and mode of administration related to the respective interventions.
Control group
Placebo

Outcomes
Primary outcome [1] 291194 0
The primary outcome is the reduction of the level of microorganisms after rinsing with the tested products. Two oropharynx swabs are collected in the timepoints 0 - before the use of the medicine, and 30 minutes later. Sowings in the media are done and after counting of microorganisms, we obtain a relation between the beta-hemolytic bacteria and the total Estreptococcus from the material collected and we convert it to a UFC/cm2 number of the tonsilar area.
Timepoint [1] 291194 0
Two oropharynx swabs are collected in the timepoints 0 - before the use of the medicine, and 30 minutes later. The timepoint is one week after the swabs collection, when it's possible to determine the effect of the intervention due to the outcome of the microorganisms counting.
Secondary outcome [1] 306213 0
Improvement of the pharyngitis by clinical evaluation.
Timepoint [1] 306213 0
The timepoint is one week after the swabs collection.

Eligibility
Key inclusion criteria
Subjects presenting complaining of odinophagy from varied etiology,with up to 48 hours of evolution, recruited in private clinics of Otorhinolaryngology and invited to participate in the clinical trial after being attended and received medical assistance.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women and patients with malignant tumors of the oral cavity and pharynx.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/12/2013
Date of last participant enrolment
Anticipated
30/01/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 5726 0
Brazil
State/province [1] 5726 0
Rio de Janeiro

Funding & Sponsors
Funding source category [1] 288513 0
Commercial sector/Industry
Name [1] 288513 0
Laboratorio Daudt Oliveira LTDA
Country [1] 288513 0
Brazil
Primary sponsor type
Commercial sector/Industry
Name
Laboratorio Daudt Oliveira Ltda
Address
57, Simoes da Mota
Turiacu, Rio de Janeiro/ RJ
Zip code: 21540-100
Country
Brazil
Secondary sponsor category [1] 287219 0
None
Name [1] 287219 0
Address [1] 287219 0
Country [1] 287219 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290376 0
Ethics Committee in Research of the University of HUPE-UERJ
Ethics committee address [1] 290376 0
77, Boulevard 28 de setembro
Vila Isabel, Rio de Janeiro - RJ
Zip code: 20.551-030
Ethics committee country [1] 290376 0
Brazil
Date submitted for ethics approval [1] 290376 0
Approval date [1] 290376 0
10/07/2013
Ethics approval number [1] 290376 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes
The Malvatricin 'Registered Trademark' is a mouthwash registered in Brazil for more than 50 years. It is consolidated in brazilian market. This study is necessary for the revalidation process in our regulatory agency - ANVISA.
There are no risks involved in this study, even because there is no evidenced adverse effect.
Related to the study, the mouthwash containing placebo is necessary in order to compare the level of reduction of microorganisms with the experimental group. Immediately after rinsing and collecting material through the oropharynx swabs, all patients will begin a treatment prescribed by an otorhinolaringologist specialist for each clinical condition presented.

Contacts
Principal investigator
Name 45346 0
Dr Eduardo Muniz Barretto Tinoco
Address 45346 0
Universitary Hospital Pedro Ernesto/ UERJ
524, Sao Francisco Xavier
Maracana, Rio de Janeiro - RJ
Zip code: 20550-013
Country 45346 0
Brazil
Phone 45346 0
+55 21 2247-7493
Fax 45346 0
Email 45346 0
[email protected]
Contact person for public queries
Name 45347 0
Mrs Michele Vieira Espindola
Address 45347 0
Laboratorio Daudt Oliveira Ltda
57, Simoes da Mota
Rio de Janeiro - RJ
Zip code: 21540100
Country 45347 0
Brazil
Phone 45347 0
+55 21 3369-8552
Fax 45347 0
Email 45347 0
[email protected]
Contact person for scientific queries
Name 45348 0
Dr Eduardo Muniz Barretto Tinoco
Address 45348 0
Universitary Hospital Pedro Ernesto/ UERJ
524, Sao Francisco Xavier
Maracana, Rio de Janeiro - RJ
Zip code: 20550-013
Country 45348 0
Brazil
Phone 45348 0
+55 21 2247-7493
Fax 45348 0
Email 45348 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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