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

Dr. August Wolff

Status: Completed

Conditions: Sore-throat; Upper Respiratory Infection

Treatments: Device: Placebo (WO 6608); Device: Verum (WO 6607)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06244615

LSMR-01/2022

Details and patient eligibility

About

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.

Enrollment: 154 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects having clinical signs and symptoms of recent (less than 48 h) acute sore throat (upper respiratory tract infection) without signs of lower respiratory tract infection (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 criteria

• Known allergy to any of the components in the investigational product (Placebo or Verum) (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 rapid screening test).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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154 participants in 2 patient groups, including a placebo group

Verum mouth and throat rinse

Experimental group

Description:

Formulation containing WO 6607 for oral administration (rinse and gargle).

Treatment:

Device: Verum (WO 6607)

Placebo mouth and throat rinse

Placebo Comparator group

Description:

Formulation containing WO 6608 for oral administration (rinse and gargle).

Treatment:

Device: Placebo (WO 6608)