Comparative study on mucoadhesive changing effects on saliva by sucking a new polysaccharide containing formulation after single dosing in patients with oro-pharyngeal symptoms

Not Applicable

• Conditions: R07.0; Pain in throat

• Registration Number: DRKS00016976
• Lead Sponsor: Dr. Pfleger Arzneimittel GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-18
• Study Completion: 2019-03-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age: >18 years
• Male or female
• Redness and/or swelling of the pharyngeal cavity diag-nosed by the investigator
• Assessment of the symptom sore throat with the intensity of = 40 mm on a visual analogue scale from 0 to 100 mm
• Assessment of at least 1 further symptom (difficulty swallowing, hoarseness, tickly throat, dry mouth) with the intensity of = 40 mm on a visual analogue scale from 0 to 100 mm
• Written informed consent

Exclusion Criteria

• Pregnant or nursing women
• Visit to the doctor due to the oro-pharyngeal symptoms
• Oro-pharyngeal symptoms for more than 2 days
• Fever (= 38,5°C) on the day of clinical trial participation
• Intake of medication and/or medical devices for the treat-ment of oro-pharyngeal symptoms the day before and on the day of clinical trial participation
• Intake of analgesics 24 hours before and on the day of clinical trial participation
• Hypersensitivity against one of the ingredients
• Pathological reduction in Salivation
• Pre-existing chewing and swallowing disorder
• Participation in a clinical investigation within the past 4 weeks
• Patient who are known or suspected
o not to comply with the clinical trial directives.
o not to be reliable or trustworthy.
o not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint are changes in the perception of the oro-pharyngeal symptoms (improvement, no Change, worsening) by using a visual analogue scale (VA) during 30 minutes after start of Treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are frequency, severity, device-relationship and outcome of adverse Events and adverse device effects.