Safety and Efficacy of the Sore Throat Lozenges to Treat Acute Sore Throats
NCT ID: NCT04139681
Last Updated: 2021-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
74 participants
INTERVENTIONAL
2019-03-12
2020-03-15
Brief Summary
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Detailed Description
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The patients will visit study site twice. At the first visit (Visit 1) a screening will be performed to finally decide if patient will be included/excluded in the study. Then he or she will be taking one single lozenge under supervision of the investigating physician and acute efficacy/safety ratings recorded before intake and repeatedly every 15 minutes for 90 minutes after intake of first lozenge. He or she will be supplied with the remaining 19 lozenges in a bottle and provided with patient diaries for home recording of efficacy/safety. After four days (max 5 days) or until complete resolution of symptoms the patients were obliged to return to the study centre for final visit 2. Daily ratings of efficacy/safety was done by the patient once in the morning and once in the evening. Daily dosage was 5 lozenges per day every 3rd hour during daytime.
At final visit 2, patients will be evaluated physically by the physician at the study centre and again assessed for safety/efficacy parameters. At last, patients returned their patient diaries and remaining study medication before compensation is handed out and patients finally excluded from the study.
Conditions
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Study Design
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NA
SINGLE_GROUP
1. First suck under supervision in the study centre one lozenge and document every 15 minutes the pain on a 100mmVAS for 90 minutes
2. Receive the rest of the bottle still containing 19 lozenges and have to take them for 4 days (5 lozenges per day). The patients have to fill out a diary in the morning and in the evening filling out the Tonsillopharyngitis Score (TSS), pain on a 100mm VAS and occurrence of adverse events, intake of other medication.
3. After the end of the treatment period patients will return to the study centre for the final visit
TREATMENT
NONE
Study Groups
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A. Vogels Sore Throat Lozenges
Each patients receives 1 glass containing 20 A.Vogel Sore Throat lozenges at inclusion visit 1. They first suck under supervision in the study centre one Vogel Sore Throat lozenge and document every 15 minutes the pain 90 minutes. Patients will receive the rest of the bottle still containing 19 Vogel Sore Throat lozenges and have to take them for 4 days (5 lozenges per day, throughout the day) and record tonsillitis pain.
A. Vogels Sore Throat lozenges
5 times 1 A. Vogels sore throat lozenges daily for 4 days
Interventions
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A. Vogels Sore Throat lozenges
5 times 1 A. Vogels sore throat lozenges daily for 4 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute pharyngitis or tonsillitis with the following symptoms: Sore throat, Inflammation of the pharynx and/or tonsils
* Start of painful disease with the last 48 hours before study inclusion
* Tonsillopharyngitis Score bigger than or equal to 6 (s.attachment)
* Willingness to give blood samples and three viral throat swabs
* Written informed consent
Exclusion Criteria
* Intake of analgetically active medication within the last 12 hours prior to study start (inclusion)
* Use of local sore throat medications within the last 4 hours prior to study start (inclusion)
* Patients with symptoms of a primary bacterial pharyngitis or a bacterial superinfection
* Severe medical condition (tumors, uncontrolled hypertension, heart insufficiency, immunosuppressive diseases etc.)
* Systemic use of corticosteroids in the last month prior to study inclusion
* Allergies to substances used in the tablet
* Pregnancy or lactation
* Participation or inclusion in one or more clinical trials within the last 30 days
12 Years
75 Years
ALL
No
Sponsors
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A. Vogel AG
INDUSTRY
Responsible Party
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Principal Investigators
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Alexandar Buchkov, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Diagnostics and Consultation Center Convex
Locations
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Diagnostics and Consultation Center Convex EOOD
Sofia, , Bulgaria
Countries
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Other Identifiers
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5'000'196
Identifier Type: -
Identifier Source: org_study_id
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