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Completed

NCT Number: NCT02669446

Ectoin® Lozenges in the Treatment of Acute Viral Pharyngitis

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.

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Key information

Conditions

Acute Viral Pharyngitis Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HNO-Praxis Elmshorn, Elmshorn, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical devices

Device

traditional household remedy

Device

Primary outcomes

  1. Change in Pharyngitis symptom score evaluated by the physician

    Time frame: 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 outcomes

  1. 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

  2. Change in patient´s General condition evaluated by the physician

    Time frame: day 1 and day 7

  3. Patient´s Evaluation of tolerability

    Time frame: 7 days

    Assessment of tolerability on a numeric scale (bad-0; very good-10)

  4. physician´s Evaluation of tolerability

    Time frame: day 7

    Assessment of tolerability on a numeric scale (bad-0; very good-10)

  5. Change in number and type of adverse Events

    Time frame: 7 days

    Incidence of adverse Events and correlations with the therapy

Sponsors and collaborators

Lead sponsor

Bitop AG

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 1, 2016
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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