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

Boehringer Ingelheim

Status and phase

Completed

Phase 4

Conditions

Pharyngitis

Treatments

Drug: Ketoprofen lysine salt

Drug: Benzidamine hydrochloride

Study type

Interventional

Funder types

Industry

Identifiers

NCT02178293

1087.7

Details and patient eligibility

About

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

Enrollment

214 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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