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

Primary Purpose

Pharyngitis

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Benzidamine hydrochloride

Ketoprofen lysine salt

About this trial

This is an interventional treatment trial for Pharyngitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Benzidamine hydrochloride

Ketoprofen lysine salt

Arm Description

Outcomes

Primary Outcome Measures

Duration of analgesic effects in hours

Secondary Outcome Measures

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)

Average severity of edema and hyperemia, assessed by investigator on a 4-point-scale

Full Information

NCT ID

NCT02178293

First Posted

June 27, 2014

Last Updated

July 4, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02178293

Brief Title

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

Acronym

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"

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

September 1998 (undefined)

Primary Completion Date

May 1999 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pharyngitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

214 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Benzidamine hydrochloride

Arm Type

Active Comparator

Arm Title

Ketoprofen lysine salt

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Benzidamine hydrochloride

Intervention Type

Drug

Intervention Name(s)

Ketoprofen lysine salt

Primary Outcome Measure Information:

Title

Duration of analgesic effects in hours

Time Frame

Up to 6 hours

Secondary Outcome Measure Information:

Title

Average number of days required to obtain remission of pain

Description

day on which 2 consecutive pain measurements are both below 10 mm of the visual analog scale (VAS)

Time Frame

Up to day 8

Title

Average severity of edema and hyperemia, assessed by investigator on a 4-point-scale

Time Frame

Up to day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1087/1087.7_U00-0004.pdf

Description

Related Info

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

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