TonsillopharyngitisPhase 4NCT04139681
Safety and Efficacy of the Sore Throat Lozenges to Treat Acute Sore Throats
A Phase 4 study testing A. Vogels Sore Throat lozenges in people with Tonsillopharyngitis and Respiratory Tract Infection Viral, run by A. Vogel AG at 1 site in Bulgaria.
Trial 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 Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Tonsillopharyngitis, Respiratory Tract Infection Viral
- What is being tested?
- A. Vogels Sore Throat lozenges
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBulgaria
- Study dates
- 12 Mar 2019to 15 Mar 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Open Clinical Trial to Assess Safety and Efficacy of the Sore Throat Lozenges in Patients With Acute Sore Throats
Aim of this study is to investigate safety and efficacy of A. Vogel Sore throat lozenges for the treatment of of acute sore throats
Read the 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.
- Being tested
- A. Vogels Sore Throat lozenges
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A. Vogels Sore Throat lozengesDrug
Also called Sore Throat lozenges
5 times 1 A. Vogels sore throat lozenges daily for 4 days
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: A. Vogels Sore Throat lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 days
Secondary outcomes (16)
Change of acute throat pain on a visual analog scale (VAS)
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
Measured: 90 min
Rate and number of treatment responders at day 1,2,3,4
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.
Measured: 4 days
Total change of Tonsillopharyngitis Score (TSS) at the end of treatment
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.
Measured: 4 days
Total reduction of pain score
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
Measured: 4 days
Absolute and relative distribution of individual Tonsillopharyngitis Score (TSS) symptoms
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
Measured: 4 days
The relative number of painfree patients
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
Measured: 4 days
The average time taken to symptom resolution1
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.
Measured: 4 days
The average time to symptom resolution2
The average time required for subjective symptom resolution
Measured: 4 days
The rate and kind of concomitant medication use
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
Measured: 4 days
The throat status as assessed by the investigating physician
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.
Measured: 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
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"
Measured: 4 days
Rate of treatment acceptance (yes) by the patient
The rate of treatment acceptance assessed by asking patients if they would retake the IMP (yes) or refuse (no) at final visit 2.
Measured: 4 days
The rate and kind of occuring adverse events
The rate and kind of occuring adverse events assessed at visit 2 and analyzed in descriptive manner
Measured: 4 days
Rate of "good" and "very good" tolerability ratings vs. "moderate" and "bad" efficacy ratings as assessment by the patient
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"
Measured: 4 days
Rate and kind of clinically relevant changes in vital parameters as assed by physical examination by the investigating physician
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
Measured: 4 days
Rate and kind of clinically relevant changes in blood parameters examined by the investigating physician
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
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start12 Mar 2019
- Primary completion26 Apr 2019
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TonsillopharyngitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Vogel AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandar Buchkov, Dr. med., Principal investigator, Diagnostics and Consultation Center Convex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139681
- Sponsor's protocol ID
- 5'000'196
- Status last verified
- Aug 2021
- First submitted
- 22 Oct 2019
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Clinical Trial to Assess Safety and Efficacy of the Sore Throat Lozenges in Patients With Acute Sore Throats
- ClinicalTrials.gov ID
- NCT04139681
- Acronym / sponsor ID
- 5'000'196
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- A. Vogel AGIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| A. Vogels Sore Throat Lozenges | Experimental | Drug: A. Vogels Sore Throat lozengesEach 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. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A. Vogels Sore Throat lozengesAlso: Sore Throat lozenges5 times 1 A. Vogels sore throat lozenges daily for 4 days | Drug | A. Vogels Sore Throat Lozenges |
Primary outcome
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
16 secondary outcomes
Change of acute throat pain on a visual analog scale (VAS)
Time frame: 90 min
Rate and number of treatment responders at day 1,2,3,4
Time frame: 4 days
Total change of Tonsillopharyngitis Score (TSS) at the end of treatment
Time frame: 4 days
Total reduction of pain score
Time frame: 4 days
Absolute and relative distribution of individual Tonsillopharyngitis Score (TSS) symptoms
Time frame: 4 days
The relative number of painfree patients
Time frame: 4 days
The average time taken to symptom resolution1
Time frame: 4 days
The average time to symptom resolution2
Time frame: 4 days
The rate and kind of concomitant medication use
Time frame: 4 days
The throat status as assessed by the investigating physician
Time frame: 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
Time frame: 4 days
Rate of treatment acceptance (yes) by the patient
Time frame: 4 days
The rate and kind of occuring adverse events
Time frame: 4 days
Rate of "good" and "very good" tolerability ratings vs. "moderate" and "bad" efficacy ratings as assessment by the patient
Time frame: 4 days
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 blood parameters examined by the investigating physician
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandar Buchkov, Dr. med. principal investigator
Diagnostics and Consultation Center Convex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing A. Vogels Sore Throat lozenges in people with Tonsillopharyngitis and Respiratory Tract Infection Viral, run by A. Vogel AG at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of "good" and "very good" tolerability ratings vs. "moderate" and "bad" tolerability ratings as assessment by a physician (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.