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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04139681
Recruitment Status : Completed
First Posted : October 25, 2019
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
A. Vogel AG

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

Condition or disease Intervention/treatment Phase
Tonsillopharyngitis Respiratory Tract Infection Viral Drug: A. Vogels Sore Throat lozenges Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Clinical Trial to Assess Safety and Efficacy of the Sore Throat Lozenges in Patients With Acute Sore Throats
Actual Study Start Date : March 12, 2019
Actual Primary Completion Date : April 26, 2019
Actual Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
Experimental: 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.
Drug: A. Vogels Sore Throat lozenges
5 times 1 A. Vogels sore throat lozenges daily for 4 days
Other Name: Sore Throat lozenges




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change of acute throat pain on a visual analog scale (VAS) [ Time Frame: 90 min ]
    Change of acute throat pain (pain reduction) on a visual analog scale (VAS) ranging from 0 millimeters (no pain) to 100 millimeters (most severe pain) within 90 minutes compared to baseline

  2. Rate and number of treatment responders at day 1,2,3,4 [ Time Frame: 4 days ]
    Rate and number of Treatment responders expressed on a Tonsillopharyngitis Score (TSS) measuring change of sore throat symptoms at day 1,2,3,4 (Responder=TSS reduction by 50% compared to baseline). The TSS score consists the following four symptoms: throat pain, difficulty in swallowing, salivation, reddening and fever (fever was defined as >38.5°C for this score) which are all rated on a scale with 0=none, 1=mild, 2=moderate, 3=severe.

  3. Total change of Tonsillopharyngitis Score (TSS) at the end of treatment [ Time Frame: 4 days ]
    Change of Tonsillopharyngitis Score (TSS) total at the end of treatment at day 4 as compared to baseline measurement. The TSS score consists the following four symptoms: throat pain, difficulty in swallowing, salivation, reddening and fever (fever was defined as >38.5°C for this score) which are all rated on a scale with 0=none, 1=mild, 2=moderate, 3=severe.

  4. Total reduction of pain score [ Time Frame: 4 days ]
    Change of acute throat pain (pain reduction) on a visual analog scale (VAS) ranging from 0 millimeters (no pain) to 100 millimeters (most severe pain) on the evenings of day 1,2,3,4 compared to baseline

  5. Absolute and relative distribution of individual Tonsillopharyngitis Score (TSS) symptoms [ Time Frame: 4 days ]
    Absolute and relative distribution of the single symptoms: throat pain, difficulty in swallowing, salivation, reddening and fever (fever was defined as >38.5°C for this score) from the Tonsillopharyngitis Score (TSS) on day 1,2,3,4 compared to baseline

  6. The relative number of painfree patients [ Time Frame: 4 days ]
    The relative number of painfree patients that experience a change of acute throat pain (pain reduction) on a visual analog scale (VAS) ranging from 0 millimeters (no pain) to 100 millimeters (most severe pain) of lower than 10 (<10) at day 1,2,3,4 compared to baseline

  7. The average time taken to symptom resolution1 [ Time Frame: 4 days ]
    The time taken to symptom resolution reaching a Tonsillopharyngitis Score (TSS) of less than 3 (<3). The TSS score consists the following four symptoms: throat pain, difficulty in swallowing, salivation, reddening and fever (fever was defined as >38.5°C for this score) which are all rated on a scale with 0=none, 1=mild, 2=moderate, 3=severe.

  8. The average time to symptom resolution2 [ Time Frame: 4 days ]
    The average time required for subjective symptom resolution

  9. The rate and kind of concomitant medication use [ Time Frame: 4 days ]
    The rate of use and kind of concomitant medication that are used by patients are recorded by questionaire as part of the patient diary and analyzed in descriptive manner

  10. The throat status as assessed by the investigating physician [ Time Frame: 4 days ]
    Throat status (reddening, swelling, inflammation) assessed by physician. Assessed are: The presence of reddening in the throat (yes/no) and swelling (light, moderate, severe) and reddening, swelling, and coating of the tonsils (yes/no). beginning vs. after 90 minutes of treatment vs. 4 days of treatment.

  11. Rate of "good" and "very good" efficacy ratings vs. "moderate" and "bad" efficacy ratings as assessment by a 1) physician 2) the patient [ Time Frame: 4 days ]
    Global subjective assessment of the subjective efficacy after acute intake of 90 minutes at visit 1 and after 4 days of continous intake at final visit 2 rated 1) by physician and 2) by the patient with "very good", "good", "moderate", "bad"

  12. Rate of treatment acceptance (yes) by the patient [ Time Frame: 4 days ]
    The rate of treatment acceptance assessed by asking patients if they would retake the IMP (yes) or refuse (no) at final visit 2.

  13. The rate and kind of occuring adverse events [ Time Frame: 4 days ]
    The rate and kind of occuring adverse events assessed at visit 2 and analyzed in descriptive manner

  14. Rate of "good" and "very good" tolerability ratings vs. "moderate" and "bad" efficacy ratings as assessment by the patient [ Time Frame: 4 days ]
    Global subjective assessment of the subjective tolerability after acute intake of 90 minutes at visit 1 and after 4 days of continous intake at final visit 2 rated by the patient with "very good", "good", "moderate", "bad"

  15. Rate and kind of clinically relevant changes in vital parameters as assed by physical examination by the investigating physician [ Time Frame: 4 days ]
    Rate and kind of clinically relevant changes in vital parameters (pulse, both blood pressure, body temperature) derived from exhamination by investigating physician at inclusion visit 1 and at final visit 2

  16. Rate and kind of clinically relevant changes in blood parameters examined by the investigating physician [ Time Frame: 4 days ]
    Rate and kind of clinically relevant changes in blood parameters measured from haematological and biochemical analysis of blood samples analyses as asssessed by the investigating physician. Laboratory blood values that are measured: ALAT, ASAT, total bilirubin, plasma glucose, serum creatinine, ESR (1h), CRP, total cholesterol, erythrocytes, MCHC, MCH, MCV, hematocrit, hemoglobin, leukocytes, and thrombocytes] derived from clinical laboratory analyses and assessed by investigating physician at visit 1 and compared to measurements at final visit 2



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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139681


Locations
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Bulgaria
Diagnostics and Consultation Center Convex EOOD
Sofia, Bulgaria, 1680
Sponsors and Collaborators
A. Vogel AG
Investigators
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Principal Investigator: Alexandar Buchkov, Dr. med. Diagnostics and Consultation Center Convex
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Responsible Party: A. Vogel AG
ClinicalTrials.gov Identifier: NCT04139681    
Other Study ID Numbers: 5'000'196
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pharyngitis
Virus Diseases
Infections
Respiratory Tract Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Menthol
Antipruritics
Dermatologic Agents