The efficacy of a Flurbiprofen drug intervention on the relief of sore throat due to upper respiratory tract infection.

Phase 3

Completed

• Conditions: Sore throat due to upper respiratory infection; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12609000329268
• Lead Sponsor: Reckitt Benckiser Healthcare (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

Age: 18 to 75.
Both male and female patients may be included.
Primary diagnosis: Patients with sore throat of onset within the past 4 days
Patients who have a sore throat (greater than or equal to 6) on the Throat Soreness Scale at baseline.
Objective findings that confirm the presence of tonsillopharyngitis (greater than or equal to 5 points on the expanded 21-point Tonsillopharyngitis Assessment).
Patients who have given written informed consent.

Exclusion Criteria

Any previous history of allergy or known intolerance to the study drug or the following formulation constituents xylitol, mannitol, carbomer 974P, sodium bicarbonate, mint, peppermint, aspartame, citric acid, silicon dioxide
Those whose sore throat has been present for more than 4 days.
Those who have evidence of mouth breathing.
Those who have evidence of severe coughing.
Those who have any disease that can compromise breathing e.g. bronchopneumonia.
Those who have taken any medicated confectionary, throat pastille, spray, or any product with demulcent properties such as boiled sweets in the previous 2 hours.
Those who have used any sore throat medication containing a local anaesthetic within the past 4 hours.
Those who have used any analgesic, antipyretic or cold medication (e.g. decongestant, antihistamine, antitussive or throat lozenge) within the previous 8 hours.
Those who have used a longer acting or slow release analgesic during the previous 24 hours e.g. Piroxicam and Naproxen.
Those taking antibiotics during the previous 14 days
Those with any painful condition that may distract attention from sore throat pain e.g. mouth ulcers etc.
Those with a history of severe renal impairment.
Those with a history of severe hepatic impairment
Those taking warfarin and other coumarins.
Those taking carbamezepine, phenobarbitone, phenytoin, primidone, rifampicin, St Johns Wort or other drugs that induce liver enzymes in the 14 days before enrolment into the study (i.e. before first dosing day).
Those with a history of alcohol abuse or state that they regularly consume alcohol in excess of the recommended amounts (excessive alcohol >21 units per week for females and >28 units per week for males.).
Those who are glutathione-deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Those with any painful condition that requires analgesic usage.
Those unable to refrain from smoking during their stay in the investigative site.
Women of childbearing potential , who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. an oral or injectable contraceptive, an approved hormonal implant or topical patch or an intrauterine device. A women of child bearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone an hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).
Those previously randomised into the study.
Those who have participated in a clinical trial in the previous 30 days. Thirty days are calculated from time of last dosing in the prior trial to time of anticipated dosing in this trial.
Those unable in the opinion of the investigator to comply fully with the study requirements, e.g. such as those who cannot comprehend or correctly use the pain rating scales.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The area under the change from baseline curve (AUC) in severity of throat soreness from 0 to 2 hours after the first dose of study medication. This is assessed with a sore throat rating scale questionnaire.[Assessments are performed at baseline and then at 1 minute after first dose, then every 5 minutes for the first 15 minutes, then every 15 minutes up to 3 hours. Then again at 4 hours, 5 hours and 6 hours post first dose.]