Safety and Efficacy of the Sore Throat Lozenges to Treat Acute Sore Throats

NCT04139681 | Completed Phase 4

• 1 other identifier: 5'000'196
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

Tonsillopharyngitis; Respiratory Tract Infection Viral

Outcome Measures

Primary Outcomes (1)

• Rate of "good" and "very good" tolerability ratings vs. "moderate" and "bad" tolerability ratings as assessment by a physician

  Assessment of safety after acute intake of 90 minutes at visit 1 and after 4 days of continous intake at final visit 2 by physician with very good, good, moderate, bad

  4 days

Secondary Outcomes (16)

• Change of acute throat pain on a visual analog scale (VAS)

  90 min

• Rate and number of treatment responders at day 1,2,3,4

  4 days

• Total change of Tonsillopharyngitis Score (TSS) at the end of treatment

  4 days

• Total reduction of pain score

  4 days

• Absolute and relative distribution of individual Tonsillopharyngitis Score (TSS) symptoms

  4 days

Study Arms (1)

A. Vogels Sore Throat Lozenges

EXPERIMENTAL

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.

Drug: A. Vogels Sore Throat lozenges

Interventions

A. Vogels Sore Throat lozenges DRUG

5 times 1 A. Vogels sore throat lozenges daily for 4 days

Also known as: Sore Throat lozenges

A. Vogels Sore Throat Lozenges

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged 12-75 years
• Acute pharyngitis or tonsillitis with the following symptoms: Sore throat, Inflammation of the pharynx and/or tonsils
• Tonsillopharyngitis Score bigger than or equal to 6 (s.attachment)
• Willingness to give blood samples and three viral throat swabs
• Written informed consent

You may not qualify if:

• Patients with symptoms of a primary bacterial pharyngitis or a bacterial superinfection
• Severe medical condition (tumors, uncontrolled hypertension, heart insufficiency, immunosuppressive diseases etc.)
• Allergies to substances used in the tablet
• Pregnancy or lactation

Sponsors & Collaborators

• A. Vogel AG: lead

Study Sites (1)

Diagnostics and Consultation Center Convex EOOD

Sofia, 1680, Bulgaria

Location

Study Officials

• Alexandar Buchkov, Dr. med.

  Diagnostics and Consultation Center Convex

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 25, 2019
• Study Start: March 12, 2019
• Primary Completion: April 26, 2019
• Study Completion: March 15, 2020
• Last Updated: August 5, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)