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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Benzydamine; Ketoprofen; Ketoprofen lysine

Criteria

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