Clinical Trial of a Mouth and Throat Rinse for the Treatment of Acute Sore Throat

Last updated: April 8, 2025
Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Overall Status: Completed

Phase

N/A

Condition

Common Cold (Pediatric)

Common Cold

Acute Rhinitis

Treatment

Placebo (WO 6608)

Verum (WO 6607)

Clinical Study ID

NCT06244615
LSMR-01/2022
  • Ages 18-75
  • All Genders

Study Summary

The aim of this study is to confirm the efficacy, safety and tolerability of the Mouth and Throat Rinse in adult participants with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis) compared to placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects having clinical signs and symptoms of recent (less than 48 h) acute sorethroat (upper respiratory tract infection) without signs of lower respiratory tractinfection (total severity score for throat irritation baseline value ≥ 4).

  • Centor Score of 0 to 3 points at screening.

  • Female and male subjects with 18-75 years of age.

Exclusion

Exclusion Criteria:

  • Known allergy to any of the components in the investigational product (Placebo orVerum) (i.e. SLS).

  • Centor Score of 4 points at screening.

  • Presence of exanthema.

  • Presence of oral mucosal plaques e.g., soor.

  • Presence of bacterial infection of the upper respiratory tract (confirmed by rapidscreening test).

Study Design

Total Participants: 154
Treatment Group(s): 2
Primary Treatment: Placebo (WO 6608)
Phase:
Study Start date:
March 25, 2024
Estimated Completion Date:
February 17, 2025

Connect with a study center

  • Central City Clinical Hospital of Ivano-Frankivsk

    Ivano-Frankivs'k,
    Ukraine

    Site Not Available

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