Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis

Acute Viral Pharyngitis Clinical Trial

Official title:

Non Interventional Clinical Investigation of Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02669446
• Other study ID #: 2016/EHT/NIS
• Status: Completed
• Phase: N/A
• First received: January 21, 2016
• Last updated: June 20, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Bitop AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Viral Pharyngitis
• Pharyngitis

Intervention

Device:
• Medical devices

• traditional household remedy

Locations

Country	Name	City	State
Germany	HNO-Praxis Mahlstedt	Berlin
Germany	HNO-Praxis Elmshorn	Elmshorn
Germany	HNO-Praxis Möller	Lüneburg
Germany	HNO-Praxis	Norderstedt

Sponsors (1)

Lead Sponsor	Collaborator
Bitop AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pharyngitis symptom score evaluated by the physician	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	day 1 and day 7	No
Secondary	Change in Pharyngitis symptoms evaluated on patient´s diaries	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	7 days	No
Secondary	Change in patient´s General condition evaluated by the physician		day 1 and day 7	No
Secondary	Patient´s Evaluation of tolerability	Assessment of tolerability on a numeric scale (bad-0; very good-10)	7 days	No
Secondary	physician´s Evaluation of tolerability	Assessment of tolerability on a numeric scale (bad-0; very good-10)	day 7	No
Secondary	Change in number and type of adverse Events	Incidence of adverse Events and correlations with the therapy	7 days	Yes