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

Last updated: July 4, 2014
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

4

Condition

Pharyngitis

Treatment

N/A

Clinical Study ID

NCT02178293
1087.7
  • Ages 18-70
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 orseverely intense (score ≥ 2) from the scoring scale from 0 to 3

  • Release of written informed consent by the patient

Exclusion

Exclusion Criteria:

  • Patients suffering from a microbial infection requiring specific antimicrobialtreatment

  • Patients who have taken the trial drugs during the week before enrolment

  • Patients who have taken corticosteroids or antibiotics during the week beforeenrolment

  • Ascertained or suspected hypersensitivity to trial drugs or to chemically correlateddrugs 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 theprotocol

  • Ascertained or presumed pregnant or lactating women

  • Inclusion in any other clinical trial during the study

Study Design

Total Participants: 214
Study Start date:
September 01, 1998
Estimated Completion Date: