CompletedPhase 3ACTRN12609000329268

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

A multi-centre, randomised, double-blinded, placebo-controlled, parallel group, multiple dose, study of the efficacy of 8.75 mg flurbiprofen micro granules in the relief of sore throat due to upper respiratory tract infection.

Sponsor

Reckitt Benckiser Healthcare (UK)

Enrollment

370 participants

Start Date

May 10, 2009

Study Type

Interventional

Conditions

Sore throat due to upper respiratory infection

Summary

This study is testing a new treatment for sore throat called flurbiprofen micro granules. Flurbiprofen lozenges are approved by the Australian health authority, the Therapeutic Goods Administration (TGA) for the relief of pain, swelling and inflammation due to severe sore throat. In this study, tiny granules of flurbiprofen will be tested to determine if they too are effective in the relief of sore throat.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a flurbiprofen lozenge for relieving sore throat caused by upper respiratory tract infection. It is for adults aged 18 to 75 who have had a sore throat for no more than 4 days. Participation involves taking the study lozenge and rating your throat pain at regular intervals over several hours.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Investigational treatment: 8.75mg flurbiprofen micro granules or placebo granules, granules are tipped from the sachet onto the tongue and dissolve instantly. Each sachet will contain either 8.75mg o

Investigational treatment: 8.75mg flurbiprofen micro granules or placebo granules, granules are tipped from the sachet onto the tongue and dissolve instantly. Each sachet will contain either 8.75mg of flurbiprofen or a placebo. The granules are are administered at the participant's discretion every 3 to 6 hours so long as they do not exceed the maximum recommended dose of 5 sachets per day. The participant will be provided with sufficient granules to last up to 3 days. Rescue medication: Paracetamol 500mg, 2 tablets orally, every 4 hours as required up to a maximum of 8 tablets per day. The participant will be provided with sufficient rescue medication to last up to 3 days. The resue medication is consumed in conjunction with the investigational treatment.

Locations(1)

Australia

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ACTRN12609000329268