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

Pharyngitis Clinical Trial

— MISTRAL  

Official title:

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02178293
• Other study ID #: 1087.7
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2014
• Last updated: July 4, 2014
• Start date: September 1998

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. primary completion date: May 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pharyngitis

Intervention

Drug:
• Benzidamine hydrochloride

• Ketoprofen lysine salt

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of analgesic effects in hours		Up to 6 hours	No
Secondary	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	No
Secondary	Average severity of edema and hyperemia, assessed by investigator on a 4-point-scale		Up to day 8	No

External Links

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