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OpenTrials
Completed

NCT Number: NCT02178293

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

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

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Key information

Conditions

Pharyngitis Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benzidamine hydrochloride

Drug

Ketoprofen Lysine Salt

Drug

Primary outcomes

  1. Duration of analgesic effects in hours

    Time frame: Up to 6 hours

Secondary outcomes

  1. Average number of days required to obtain remission of pain

    Time frame: Up to day 8

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

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

    Time frame: Up to day 8

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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"

Acronym: MISTRAL

Important dates

Study start
1998
Primary completion
1999
First posted
Jun 30, 2014
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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