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

NCT04203810 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2022-07-28

No results posted yet for this study

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.

Conditions

  • Sore Throat
  • Acute Pharyngitis
  • Cough

Interventions

DEVICE

Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)

4 puffs to be administered as needed several times a day for patients aged ≥ 12 years. A maximum of 10 applications per day should not be exceeded.

DEVICE

EMSER® Hals-und Rachenspray (throat spray)

1 to 3 puffs to be administered several times a day

Sponsors & Collaborators

  • Bitop AG

    lead INDUSTRY

Principal Investigators

  • Ralph Moesges, Prof. Dr. · ClinCompetence GmbH, Genter Str. 7, 50672 Cologne, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-14
Primary Completion
2020-12-04
Completion
2020-12-04

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04203810 on ClinicalTrials.gov