Clinical trial NCT04139681: Safety and Efficacy of the Sore Throat Lozenges to Treat Acute Sore Throats
Official title: Open Clinical Trial to Assess Safety and Efficacy of the Sore Throat Lozenges in Patients With Acute Sore Throats
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tonsillopharyngitis
Respiratory Tract Infection Viral
Lead sponsor: A. Vogel AG
Sponsor class: INDUSTRY
First posted: 2019-10-25
Enrollment: 74
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Eligible patients fulfilling the inclusion criteria will :

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
Primary purpose: TREATMENT

Brief summary: Aim of this study is to investigate safety and efficacy of A. Vogel Sore throat lozenges for the treatment of of acute sore throats

Detailed description: 75 patients aged 12-75 years with acute sore throats (symptoms not older than 48 h) were recruited by the study site/CRO via local general practitioners and are allocated to acute treatment with A. Vogel Sore throat lozenges. The patients who are confirmed to meet the study entry criteria and after having given written informed consent will be assigned to receive a study treatment according to study procedures described in the study plan.

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.

Eligibility criteria: Inclusion Criteria:

* Men and women aged 12-75 years
* 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:

* Pharyngitis or tonsillitis more than 48 hours before study start (inclusion)
* 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

Primary outcomes:
measure: Rate of "good" and "very good" tolerability ratings vs. "moderate" and "bad" tolerability ratings as assessment by a physician
timeFrame: 4 days
Secondary outcomes:
measure: Change of acute throat pain on a visual analog scale (VAS)
timeFrame: 90 min
measure: Rate and number of treatment responders at day 1,2,3,4
timeFrame: 4 days
measure: Total change of Tonsillopharyngitis Score (TSS) at the end of treatment
timeFrame: 4 days
measure: Total reduction of pain score
timeFrame: 4 days
measure: Absolute and relative distribution of individual Tonsillopharyngitis Score (TSS) symptoms
timeFrame: 4 days
measure: The relative number of painfree patients
timeFrame: 4 days
measure: The average time taken to symptom resolution1
timeFrame: 4 days
measure: The average time to symptom resolution2
timeFrame: 4 days
measure: The rate and kind of concomitant medication use
timeFrame: 4 days
measure: The throat status as assessed by the investigating physician
timeFrame: 4 days
measure: Rate of "good" and "very good" efficacy ratings vs. "moderate" and "bad" efficacy ratings as assessment by a 1) physician 2) the patient
timeFrame: 4 days
measure: Rate of treatment acceptance (yes) by the patient
timeFrame: 4 days
measure: The rate and kind of occuring adverse events
timeFrame: 4 days
measure: Rate of "good" and "very good" tolerability ratings vs. "moderate" and "bad" efficacy ratings as assessment by the patient
timeFrame: 4 days
measure: Rate and kind of clinically relevant changes in vital parameters as assed by physical examination by the investigating physician
timeFrame: 4 days
measure: Rate and kind of clinically relevant changes in blood parameters examined by the investigating physician
timeFrame: 4 days
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Diagnostics and Consultation Center Convex EOOD
Study officials:
affiliation: Diagnostics and Consultation Center Convex
name: Alexandar Buchkov, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: