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Completed NCT04203810

Effectiveness and Tolerability of Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)

Conditions: Sore Throat, Acute Pharyngitis, Cough

Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 194
Sponsor: Bitop AG

Location: Dr. Pasch Aachen

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.

Eligibility Criteria

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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04203810). StuddyBuddy aggregates publicly available trial information.