Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis

Completed

• Conditions: Acute Viral Pharyngitis
• Interventions: Device: Medical devices; Device: traditional household remedy

• Registration Number: NCT02669446
• Lead Sponsor: Bitop AG

Brief Summary

This a comparative, open label, parallel group, non interventional study which compares the tolerability and influence of Ectoin containing Lozenges to saline solution and lozenges containing hyaluronic acid for the treatment of acute viral Pharyngitis. The observation takes place over a period of 7 days. Response to treatment is recorded at day 1 and day 7 by the physician and by the patient in a dairy.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-02-01
• Primary Completion: 2016-05
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-20
• Last Update Posted: 2016-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients with acute Pharyngitis according to instruction for use
• Female or male individuals ≥ 18 years
• Agreement to abide by the routinely provided doctor's appointment for follow- up (reflected in the planned visits of observation plan resist)

Exclusion Criteria

• Contraindications according to instructions for use
• Male or female person under 18 years
• Sore throat for more than 5 days
• Any disease that can, in the opinion of the treating physician to affect the outcome of the study.
• Patients with known intolerance to one of the substances used
• Surgical procedures to the mouth and throat in the last 6 weeks before inclusion in the NIS
• Bacterial Pharyngitis
• Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid containing lozenges	Medical devices	treatment with hyaluronic acid containing lozenges
Ectoin containing Lozenges	Medical devices	treatment with Ectoin containing lozenges
Saline solution for gargling	traditional household remedy	Subjects in were requested to gargle with salt water

Primary Outcome Measures

Name	Time	Method
Change in Pharyngitis symptom score evaluated by the physician	day 1 and day 7	The intensity of the symptoms and signs will be graded on a continuous numeric scale, i.e. absent-0, severe-10.; The following signs and symptoms will be documented: * pain on swallowing; * tickle in the throat; * hoarseness; * dry mouth and throat; * burning of throat; * patient´s General condition; * reddening of the oropharynx; * reddening of the larynx

Secondary Outcome Measures

Name	Time	Method
Patient´s Evaluation of tolerability	7 days	Assessment of tolerability on a numeric scale (bad-0; very good-10)
Change in number and type of adverse Events	7 days	Incidence of adverse Events and correlations with the therapy
Change in Pharyngitis symptoms evaluated on patient´s diaries	7 days	The intensity of the symptoms and signs will be graded on a continuous numeric scale, i.e. absent-0, severe-10.; The following signs and symptoms will be documented: * pain on swallowing; * tickle in the throat; * hoarseness; * dry mouth and throat; * burning of throat; * patient´s General condition
physician´s Evaluation of tolerability	day 7	Assessment of tolerability on a numeric scale (bad-0; very good-10)
Change in patient´s General condition evaluated by the physician	day 1 and day 7

Trial Locations

Locations (4)

HNO-Praxis Möller; 🇩🇪 Lüneburg, Germany

HNO-Praxis Mahlstedt; 🇩🇪 Berlin, Germany

HNO-Praxis; 🇩🇪 Norderstedt, Germany

HNO-Praxis Elmshorn; 🇩🇪 Elmshorn, Germany