Ketoprofen Lysine Salt as Mouthwash in Acute Phlogosis of the Pharyngeal Cavity Versus Benzidamine Hydrochloride

Study Overview
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Brief Summary
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A study to in order to verify any differences between the 2 treatment groups in terms of duration of analgesic effects after the first drug intake and time to remission of symptoms and signs of pharyngitis

Official Title
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MISTRAL (Mouthwash In Sore Throat Relief: Antiinflammatory vs. Local Anesthetic Therapy) Efficacy and Tolerability of Ketoprofen Lysine Salt as a Mouthwash in Acute Phlogosis of the Pharyngeal Cavity; Multicentre, Randomized, Single-blind, Parallel-group Comparison Versus Benzidamine Hydrochloride

Conditions
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Pharyngitis

Intervention / Treatment
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* Drug: Benzidamine hydrochloride
* Drug: Ketoprofen lysine salt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female outpatients, aged 18 to 70 years, suffering from acute pharyngitis, pharyngolaryngitis Moderately or severely intense pain in the pharyngeal region (score ≥ 70 mm) from the visual analogue scale (VAS) At least 1 of the 2 inflammation signs (edema and hyperemia) to be moderately or severely intense (score ≥ 2) from the scoring scale from 0 to 3 Release of written informed consent by the patient Exclusion Criteria: Patients suffering from a microbial infection requiring specific antimicrobial treatment Patients who have taken the trial drugs during the week before enrolment Patients who have taken corticosteroids or antibiotics during the week before enrolment Ascertained or suspected hypersensitivity to trial drugs or to chemically correlated drugs or to other non-steroidal anti-inflammatory drugs or to mouthwashes in general Patients who are unable to properly fill in the diary every day as provided for by the protocol Ascertained or presumed pregnant or lactating women Inclusion in any other clinical trial during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Benzidamine hydrochloride<br> | Drug: Benzidamine hydrochloride<br> <br> |
| Experimental: Ketoprofen lysine salt<br> | Drug: Ketoprofen lysine salt<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of analgesic effects in hours |  | Up to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average number of days required to obtain remission of pain | day on which 2 consecutive pain measurements are both below 10 mm of the visual analog scale (VAS) | Up to day 8 | 
| Average severity of edema and hyperemia, assessed by investigator on a 4-point-scale |  | Up to day 8 |