Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.
Non-interventional Study to Investigate the Application of Ectoin Containing Lozenges (EHT02) in Patients With Acute, Viral Pharyngitis.
1 other identifier
observational
102
1 country
1
Brief Summary
The goal of this non-interventional study is to investigate the safety, efficacy and tolerability of Ectoin Lozenges Honey Lemon (EHT02) compared to lozenges containing hyaluronic acid and islandic moss in the treatment of acute viral pharyngitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 13, 2018
CompletedFirst Submitted
Initial submission to the registry
January 21, 2019
CompletedFirst Posted
Study publicly available on registry
May 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2019
CompletedJuly 10, 2019
July 1, 2019
5 months
January 21, 2019
July 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Pharyngitis symptom score evaluated by the physician
The intensity of the symptoms 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 * hoarseness * urge to cough * dry mouth and throat * reddening of oropharynx * reddening of larynx * sore throat * impairment of free breathing * patient's general condition
day 1 and day 7
Secondary Outcomes (8)
Change in Pharyngitis Symptoms evaluated in patient's diaries
7 days
Change of Saliva production evaluated by the physician
day 7
Evaluation how efficient the treatment is judged by physician
day 7
Evaluation how efficient the treatment is judged by patient
7 days
Evaluation how treatment is tolerated (judged by physician)
day 7
- +3 more secondary outcomes
Study Arms (2)
Ectoin Lozenges Honey Lemon
application of 1 Lozenge every three hours or as often as required, not more than 10 lozenges per day
Hyaluronic acid/Icelandic moss Lozenges
application as often as required, not more than 6 lozenges per day
Interventions
application of Ectoin Lozenges (EHT02) in accordance with the instructions for use
application of the lozenges in accordance with the instructions for use
Eligibility Criteria
patients diagnosed with acute viral pharyngitis
You may qualify if:
- patients with acute viral pharyngitis
You may not qualify if:
- patients with known intolerance to one of the substances used
- Pregnancy
- Surgical Procedures in the mouth and throat region prior to the study
- Bacterial Pharyngitis
- symptoms in the throat since more than 5 days
- Contraindications according to the instructions for use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bitop AGlead
Study Sites (1)
bitop AG
Dortmund, 44263, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andreas Bilstein, Dr
CSO
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2019
First Posted
May 9, 2019
Study Start
December 13, 2018
Primary Completion
May 13, 2019
Study Completion
May 13, 2019
Last Updated
July 10, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share