Clinical Trial: Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:
Sponsor: Bitop AG

Current Primary Outcome: Change in Pharyngitis symptom score evaluated by the physician [ Time Frame: day 1 and day 7 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in Pharyngitis symptoms evaluated on patient´s diaries [ Time Frame: 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
• Change in patient´s General condition evaluated by the physician [ Time Frame: day 1 and day 7 ]
• Patient´s Evaluation of tolerability [ Time Frame: 7 days ]
  Assessment of tolerability on a numeric scale (bad-0; very good-10)
• physician´s Evaluation of tolerability [ Time Frame: day 7 ]
  Assessment of tolerability on a numeric scale (bad-0; very good-10)
• Change in number and type of adverse Events [ Time Frame: 7 days ]
  Incidence of adverse Events and correlations with the therapy

Original Secondary Outcome: Same as current

Information By: Bitop AG

Dates:
Date Received: January 21, 2016
Date Started: January 2016
Date Completion:
Last Updated: June 20, 2016
Last Verified: June 2016