Ketoprofen Lysine Salt as Mouthwash in Acute Phlogosis of the Pharyngeal Cavity Versus Benzidamine Hydrochloride
MISTRAL
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"
1 other identifier
interventional
214
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 1999
CompletedFirst Submitted
Initial submission to the registry
June 27, 2014
CompletedFirst Posted
Study publicly available on registry
June 30, 2014
CompletedJuly 8, 2014
July 1, 2014
8 months
June 27, 2014
July 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of analgesic effects in hours
Up to 6 hours
Secondary Outcomes (2)
Average number of days required to obtain remission of pain
Up to day 8
Average severity of edema and hyperemia, assessed by investigator on a 4-point-scale
Up to day 8
Study Arms (2)
Benzidamine hydrochloride
ACTIVE COMPARATORKetoprofen lysine salt
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2014
First Posted
June 30, 2014
Study Start
September 1, 1998
Primary Completion
May 1, 1999
Last Updated
July 8, 2014
Record last verified: 2014-07