Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis

NCT02669446 | Completed DMC

• 1 other identifier: 2016/EHT/NIS
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 4

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.

Conditions

Acute Viral Pharyngitis

Keywords

Non interventional study; Ectoin; Lozenges; pharyngitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Change in Pharyngitis symptoms evaluated on patient´s diaries

  7 days

• Change in patient´s General condition evaluated by the physician

  day 1 and day 7

• Patient´s Evaluation of tolerability

  7 days

• physician´s Evaluation of tolerability

  day 7

• Change in number and type of adverse Events

  7 days

Study Arms (3)

Ectoin containing Lozenges

treatment with Ectoin containing lozenges

Device: Medical devices

Hyaluronic acid containing lozenges

treatment with hyaluronic acid containing lozenges

Device: Medical devices

Saline solution for gargling

Subjects in were requested to gargle with salt water

Device: traditional household remedy

Interventions

Medical devices DEVICE

Ectoin containing Lozenges; Hyaluronic acid containing lozenges

traditional household remedy DEVICE

Saline solution for gargling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with viral pharyngitis

You may qualify if:

• 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)

You may not qualify if:

• 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
• Bacterial Pharyngitis
• Pregnancy

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (4)

HNO-Praxis Elmshorn

Elmshorn, Elmshorn, 25337, Germany

Location

HNO-Praxis Mahlstedt

Berlin, 10452, Germany

Location

HNO-Praxis Möller

Lüneburg, 21335, Germany

Location

HNO-Praxis

Norderstedt, 22846, Germany

Location

MeSH Terms

Conditions

Pharyngitis

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Uwe Sonnemann, MD

  HNO-Praxis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: February 1, 2016
• Study Start: January 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 21, 2016

Record last verified: 2016-06

Locations

DE (4)