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

A. Vogel AG

Status and phase: Completed; Phase 4

Conditions: Tonsillopharyngitis; Respiratory Tract Infection Viral

Treatments: Drug: A. Vogels Sore Throat lozenges

Study type: Interventional

Funder types: Industry

Identifiers

NCT04139681

5'000'196

Details and patient eligibility

About

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

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

A. Vogels Sore Throat Lozenges

Experimental group

Description:

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.

Treatment:

Drug: A. Vogels Sore Throat lozenges