Acute Viral PharyngitisNCT02669446
Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis
An observational study of Acute Viral Pharyngitis, run by Bitop AG at 4 sites in Germany.
Trial summary
This a comparative, open label, parallel group, non interventional study which compares the tolerability and influence of Ectoin containing Lozenges to saline solution and lozenges containing hyaluronic acid for the treatment of acute viral Pharyngitis. The observation takes place over a period of 7 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Viral Pharyngitis
- What is being tested?
- Medical devices and traditional household remedy
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 4 sitesGermany
- Study dates
- Jan 2016to Jun 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with viral pharyngitis
Who may be able to join
- Patients with acute Pharyngitis according to instruction for use
- Female or male individuals ≥ 18 years
- Agreement to abide by the routinely provided doctor's appointment for follow- up (reflected in the planned visits of observation plan resist)
Who cannot join
- Contraindications according to instructions for use
- Male or female person under 18 years
- Sore throat for more than 5 days
- Any disease that can, in the opinion of the treating physician to affect the outcome of the study.
- Patients with known intolerance to one of the substances used
- Surgical procedures to the mouth and throat in the last 6 weeks before inclusion in the NIS
- Bacterial Pharyngitis
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
HNO-Praxis Mahlstedt
Berlin, 10452
HNO-Praxis Elmshorn
Elmshorn, Elmshorn, 25337
HNO-Praxis Möller
Lüneburg, 21335
HNO-Praxis
Norderstedt, 22846
About this study
Official title: Non Interventional Clinical Investigation of Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis
This a comparative, open label, parallel group, non interventional study which compares the tolerability and influence of Ectoin containing Lozenges to saline solution and lozenges containing hyaluronic acid for the treatment of acute viral Pharyngitis. The observation takes place over a period of 7 days. Response to treatment is recorded at day 1 and day 7 by the physician and by the patient in a dairy.
- Conditions
- Acute Viral Pharyngitis
- Being tested
- Medical devices, traditional household remedy
- Keywords
- Non interventional study, Ectoin, Lozenges, pharyngitis
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical devicesDevice
traditional household remedyDevice
| Study group | Role | What they receive |
|---|---|---|
| Ectoin containing Lozenges | treatment with Ectoin containing lozenges Receives: Device: Medical devices | |
| Hyaluronic acid containing lozenges | treatment with hyaluronic acid containing lozenges Receives: Device: Medical devices | |
| Saline solution for gargling | Subjects in were requested to gargle with salt water Receives: Device: traditional household remedy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pharyngitis symptom score evaluated by the physician
The intensity of the symptoms and signs will be graded on a continuous numeric scale, i.e. absent-0, severe-10.
The following signs and symptoms will be documented:
- pain on swallowing
- tickle in the throat
- hoarseness
- dry mouth and throat
- burning of throat
- patient´s General condition
- reddening of the oropharynx
- reddening of the larynx
Measured: day 1 and day 7
Secondary outcomes (5)
Change in Pharyngitis symptoms evaluated on patient´s diaries
The intensity of the symptoms and signs will be graded on a continuous numeric scale, i.e. absent-0, severe-10.
The following signs and symptoms will be documented:
- pain on swallowing
- tickle in the throat
- hoarseness
- dry mouth and throat
- burning of throat
- patient´s General condition
Measured: 7 days
Change in patient´s General condition evaluated by the physician
Measured: day 1 and day 7
Patient´s Evaluation of tolerability
Assessment of tolerability on a numeric scale (bad-0; very good-10)
Measured: 7 days
physician´s Evaluation of tolerability
Assessment of tolerability on a numeric scale (bad-0; very good-10)
Measured: day 7
Change in number and type of adverse Events
Incidence of adverse Events and correlations with the therapy
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Viral PharyngitisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uwe Sonnemann, MD, Principal investigator, HNO-Praxis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669446
- Sponsor's protocol ID
- 2016/EHT/NIS
- Status last verified
- Jun 2016
- First submitted
- 21 Jan 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Interventional Clinical Investigation of Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis
- ClinicalTrials.gov ID
- NCT02669446
- Acronym / sponsor ID
- 2016/EHT/NIS
- Conditions
- Acute Viral Pharyngitis
- Keywords
- Non interventional study, Ectoin, Lozenges, pharyngitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Feb 2016 (estimated)
- 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.
This a comparative, open label, parallel group, non interventional study which compares the tolerability and influence of Ectoin containing Lozenges to saline solution and lozenges containing hyaluronic acid for the treatment of acute viral Pharyngitis. The observation takes place over a period of 7 days. Response to treatment is recorded at day 1 and day 7 by the physician and by the patient in a dairy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ectoin containing Lozenges | – | Device: Medical devicestreatment with Ectoin containing lozenges |
| Hyaluronic acid containing lozenges | – | Device: Medical devicestreatment with hyaluronic acid containing lozenges |
| Saline solution for gargling | – | Device: traditional household remedySubjects in were requested to gargle with salt water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with viral pharyngitis
Key inclusion criteria (3 listed)
- Patients with acute Pharyngitis according to instruction for use
- Female or male individuals ≥ 18 years
- Agreement to abide by the routinely provided doctor's appointment for follow- up (reflected in the planned visits of observation plan resist)
Key exclusion criteria (8 listed)
- Contraindications according to instructions for use
- Male or female person under 18 years
- Sore throat for more than 5 days
- Any disease that can, in the opinion of the treating physician to affect the outcome of the study.
- Patients with known intolerance to one of the substances used
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 |
|---|---|---|
| Medical devices | Device | Ectoin containing Lozenges, Hyaluronic acid containing lozenges |
| traditional household remedy | Device | Saline solution for gargling |
Primary outcome
Change in Pharyngitis symptom score evaluated by the physician
Time frame: day 1 and day 7
The intensity of the symptoms and signs will be graded on a continuous numeric scale, i.e. absent-0, severe-10. The following signs and symptoms will be documented: * pain on swallowing * tickle in the throat * hoarseness * dry mouth and throat * burning of throat * patient´s General condition * reddening of the oropharynx * reddening of the larynx
5 secondary outcomes
Change in Pharyngitis symptoms evaluated on patient´s diaries
Time frame: 7 days
Change in patient´s General condition evaluated by the physician
Time frame: day 1 and day 7
Patient´s Evaluation of tolerability
Time frame: 7 days
physician´s Evaluation of tolerability
Time frame: day 7
Change in number and type of adverse Events
Time frame: 7 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 21 Jun 2016.
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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.
Uwe Sonnemann, MD principal investigator
HNO-Praxis
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Viral Pharyngitis, run by Bitop AG at 4 sites in Germany.
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 3 inclusion and 8 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 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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.
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?
Change in Pharyngitis symptom score evaluated by the physician (time frame: day 1 and day 7). 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 21 Jun 2016.