NCT06244615

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 25, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2025

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

11 months

First QC Date

December 19, 2023

Last Update Submit

April 8, 2025

Conditions

Sore-throatUpper Respiratory Infection

Outcome Measures

Primary Outcomes (1)

  • Change in total severity score of throat irritation for subjective and objective symptoms during the clinical investigation (comparison between verum and placebo)

    A total severity score for throat irritation will be calculated at each visit as the sum of the subjective and objective symptoms. Each of the four criteria on a scale from 0 to 4: 1\. soreness, 2. difficulty swallowing (rated by the subject), 3. mucosal swelling of the throat and 4. oropharyngeal color (erythema) (assessed by the investigator)

    Day 1 vs Day 4

Secondary Outcomes (11)

  • Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo by analysing the detection of viruses

    Day 1 vs. Day 2,Day 1 vs. Day 4, Day 1 vs. Day 7 and Day 1 vs. Day 14

  • Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo with respect to the subjective symtoms of throat soreness and difficulty swallowing

    Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1

  • Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the objective symptoms of mucous swelling and oropharyngeal color (erythema)

    Day 1 vs. Day 7±1 and Day 1 vs. Day 14±1

  • Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the recovery time

    Day 1 vs. Day 7 and Day 1 vs. Day 14

  • Evaluate the efficacy of the Verum Mouth and Throat Rinse compared to Placebo regarding the proportion of rebound after treatment phase

    Day 1 vs. Day 7 and Day 1 vs. Day 14

  • +6 more secondary outcomes

Study Arms (2)

Verum mouth and throat rinse

EXPERIMENTAL

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

Device: Verum (WO 6607)

Placebo mouth and throat rinse

PLACEBO COMPARATOR

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

Device: Placebo (WO 6608)

Interventions

Verum (WO 6607)DEVICE

Mouth and throat rinse and gargle solution

Verum mouth and throat rinse
Placebo (WO 6608)DEVICE

Mouth and throat rinse and gargle solution

Placebo mouth and throat rinse

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central City Clinical Hospital of Ivano-Frankivsk

Ivano-Frankivsk, Ukraine

Location

MeSH Terms

Conditions

PharyngitisRespiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Roman Fishchuk, MD

    Central City Clinical Hospital of Ivano-Frankivsk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2023

First Posted

February 6, 2024

Study Start

March 25, 2024

Primary Completion

February 17, 2025

Study Completion

February 17, 2025

Last Updated

April 11, 2025

Record last verified: 2025-04

Locations

UA(1)