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NCT02178293 Clinical Trial

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
Secondary ID
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. completion date
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

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
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