Effectiveness and Tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09) (NCT04203810) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness and Tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)
Germany194 participantsStarted 2020-01-14
Plain-language summary
The aim of this multicentre, actively controlled, randomized, open label, parallel group, prospective, comparator study is to collect data on the clinical effectiveness and tolerability of the medical device ERS09 compared to a well-established comparator spray in the symptomatic treatment of sore throat due to acute pharyngitis and dry cough.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP)/ISO14155 guidelines and local regulation prior to participation in the trial
* Individuals regardless of gender 12 years old or older
* Patients with sore throat due to acute pharyngitis and dry cough, both with an onset of symptoms no more than 72 hours prior to Visit 1
* Sore Throat Pain Intensity Score ≥ 40 mm (measured on a 100 mm visual analogue scale \[VAS\])
Exclusion Criteria:
* Hypersensitivity to Ectoin, Althaea off., Honey or any of the other ingredients of the ERS09 or the comparator
* Fructose intolerance or glucose-galactose malabsorption
* Pregnant or breast-feeding women
* Suspected bacterial pharyngitis
* Individuals younger than 12 years
* Symptoms since more than 72 hours
* Use of any pain or cough medication (i.e. analgesic/ anti-pyretic/ anti-inflammatory or mucolytic/ expectorant/ antitussive) within 24 hours preceding enrolment in the study
* Oral lesions or oral surgical procedures within 1 month prior to enrolment in the study
* Patients for who the Investigator believes will not comply with the study protocol (e.g. patients with drug abuse or with a history of a serious psychiatric disorder as well as patients unwilling to give informed consent or to abide by the requirements of the protocol)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.