Open Clinical Trial to Assess Safety and Efficacy of the Sore Throat Lozenges in Patients With Acute Sore Throats
Overview
- Phase
- Phase 4
- Intervention
- A. Vogels Sore Throat lozenges
- Conditions
- Tonsillopharyngitis
- Sponsor
- A. Vogel AG
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Rate of "good" and "very good" tolerability ratings vs. "moderate" and "bad" tolerability ratings as assessment by a physician
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Arms & Interventions
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.
Intervention: A. Vogels Sore Throat lozenges
Outcomes
Primary Outcomes
Rate of "good" and "very good" tolerability ratings vs. "moderate" and "bad" tolerability ratings as assessment by a physician
Time Frame: 4 days
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
Secondary Outcomes
- The average time to symptom resolution2(4 days)
- Rate of treatment acceptance (yes) by the patient(4 days)
- Rate of "good" and "very good" tolerability ratings vs. "moderate" and "bad" efficacy ratings as assessment by the patient(4 days)
- Rate and number of treatment responders at day 1,2,3,4(4 days)
- The average time taken to symptom resolution1(4 days)
- Change of acute throat pain on a visual analog scale (VAS)(90 min)
- 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)
- The relative number of painfree patients(4 days)
- The rate and kind of concomitant medication use(4 days)
- The throat status as assessed by the investigating physician(4 days)
- Rate of "good" and "very good" efficacy ratings vs. "moderate" and "bad" efficacy ratings as assessment by a 1) physician 2) the patient(4 days)
- The rate and kind of occuring adverse events(4 days)
- Rate and kind of clinically relevant changes in vital parameters as assed by physical examination by the investigating physician(4 days)
- Rate and kind of clinically relevant changes in blood parameters examined by the investigating physician(4 days)