Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000329268
Ethics application status
Approved
Date submitted
16/03/2009
Date registered
22/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficacy of a Flurbiprofen drug intervention on the relief of sore throat due to upper respiratory tract infection.
Scientific title
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.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sore throat due to upper respiratory infection 4481 0
Condition category
Condition code
Respiratory 4756 4756 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 4228 0
Treatment: Drugs
Comparator / control treatment
Placebo micro granule formulation (sugar micro granules). Each sachet will contain 8.75mg of placebo. Granules are tipped from the sachet onto the tongue and dissolve instantly. 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.
Control group
Placebo

Outcomes
Primary outcome [1] 5624 0
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.
Timepoint [1] 5624 0
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.
Secondary outcome [1] 9475 0
The area under the change from baseline curve (AUC) in severity of throat soreness from 0 to 6 hours post first dose. This is assessed with a sore throat rating scale questionnaire.
Timepoint [1] 9475 0
Timepoint: 0 to 6 hours post first dose.
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.
Secondary outcome [2] 9476 0
Change from baseline in severity of throat soreness (using the 11 point throat soreness scale).
Timepoint [2] 9476 0
at 1, 5, 10, 15, 30, 45, 60, 75, 90, 105,120,135,150, 165, 180, 240, 300 and 360 minutes post first dose.
Secondary outcome [3] 9477 0
Change from baseline (using 100mm visual analogue scale (VAS) sore throat pain intensity scale) in sore throat pain intensity (pain intensity difference (PID) VAS)
Timepoint [3] 9477 0
at 1, 5, 10, 15, 30, 45, 60, 75, 90, 105,120,135,150, 165, 180, 240, 300 and 360 minutes post first dose.
Secondary outcome [4] 9478 0
sum of pain intensity difference (SPID) over 0-3, 0-6 hours (using the 100 mm VAS sore throat pain intensity scale)
Timepoint [4] 9478 0
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.
Secondary outcome [5] 9479 0
Time to first reporting 'moderate sore throat relief' (which is the mid point on the 7 point sore throat relief scale).
Timepoint [5] 9479 0
From the first treatment dose until first time reporting moderate sore throat relief occurs
Secondary outcome [6] 9480 0
Total sum of pain relief ratings (TOTPAR3): Defined as the AUC from baseline to 3 hours post first dose for sore throat relief.
Timepoint [6] 9480 0
Assessments are performed 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.
Secondary outcome [7] 9481 0
Total sum of pain relief ratings (TOTPAR6): Defined as the AUC from baseline to 6 hours post first dose for sore throat relief.
Timepoint [7] 9481 0
Assessments are performed 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.
Secondary outcome [8] 9482 0
Sore throat relief
This is assessed by a sore throat relief rating scale questionnaire.
Timepoint [8] 9482 0
at 1, 5, 10, 15, 30, 45, 60, 75, 90, 105, 120,135,150,165,180,240,300 and 360 minutes post first dose.
Secondary outcome [9] 9483 0
AUC from baseline to 3 hours post first dose for the change from baseline in difficulty in swallowing. This is assessed by a difficulty swallowing rating scale questionnaire.
Timepoint [9] 9483 0
Assessments are performed baseline, 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.
Secondary outcome [10] 9484 0
Change from baseline in difficulty in swallowing (using 100mm VAS difficulty swallowing scale)
Timepoint [10] 9484 0
at 1, 5, 10, 15, 30, 45, 60, 75, 90, 105 and 120,135,150,165,180,240,300 and 360 minutes post first dose.
Secondary outcome [11] 9485 0
Time to first reporting a change of 1 or more on the Throat Soreness scale.
Timepoint [11] 9485 0
From the first treatment dose until first time reporting change of 1 or more on the Throat Soreness scale
Secondary outcome [12] 9489 0
Overall treatment rating assesses by rating scale in questionnaire.
Timepoint [12] 9489 0
At three hours following first treatment dose, and at the end of Day 3 of treatment.
Secondary outcome [13] 9490 0
Overall flurbiprofen micro granule sachet consumption as recorded in the patient diary up to the end of Day 3.
Timepoint [13] 9490 0
the end of Day 3.
Secondary outcome [14] 9491 0
Overall rescue medication (Paracetamol) consumption as recorded in the patient diary up to the end of Day 3.
Timepoint [14] 9491 0
at the end of Day 3.
Secondary outcome [15] 9492 0
Whether the patient was symptom free at the end of Day 1, at 24 hours post first dose and at the end of Days 2 and 3. Freedom from symptoms is defined as the patient giving a sore throat score of 0 or 1.
Timepoint [15] 9492 0
at the end of Day 1, at 24 hours post first dose and at the end of Days 2 and 3.
Secondary outcome [16] 9493 0
The proportion of patients that discontinued trial medication due to resolution of sore throat. This is reported by the participant via questionnaire.
Timepoint [16] 9493 0
At the completion of treatment programs

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Drug supplies will be packed and labelled according to a computer produced randomisation schedule by site. On randomisation, patients will be allocated a unique number in numerical sequence. Issue of the drug in sequence will ensure randomisation.
The investigator will be provided with the randomisation code for each patient as a code break envelope. The code will only be broken for an individual patient in an emergency case such as a serious adverse event that requires knowledge of what study drug was taken in order that the serious adverse event can be treated appropriately.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
SAS random code generator, will randomly assign patients to either placebo or active treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
370
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4671 0
Commercial sector/Industry
Name [1] 4671 0
Reckitt Benckiser Healthcare (UK)
Country [1] 4671 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Reckitt Benckiser Healthcare (UK)
Address
Dansom Lane
Hull, HU8 7DS
Country
United Kingdom
Secondary sponsor category [1] 4217 0
Commercial sector/Industry
Name [1] 4217 0
Novotech (Australia) Pty. Ltd.
Address [1] 4217 0
Level 3, 19 Harris Street
Pyrmont, N.S.W. 2009
Country [1] 4217 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6708 0
Bellberry HREC
Ethics committee address [1] 6708 0
Ethics committee country [1] 6708 0
Australia
Date submitted for ethics approval [1] 6708 0
01/04/2009
Approval date [1] 6708 0
Ethics approval number [1] 6708 0

Summary
Brief 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.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 29402 0
Address 29402 0
Country 29402 0
Phone 29402 0
Fax 29402 0
Email 29402 0
Contact person for public queries
Name 12649 0
Christopher Morris
Address 12649 0
Reckitt Benckiser Healthcare
Dansom Lane, Hull, HU8 7DS
Country 12649 0
United Kingdom
Phone 12649 0
+44 (0) 1482 582675
Fax 12649 0
+44 (0) 1482 582172
Email 12649 0
Christopher.Morris@ReckittBenckiser.com
Contact person for scientific queries
Name 3577 0
Christopher Morris
Address 3577 0
Reckitt Benckiser Healthcare
Dansom Lane, Hull, HU8 7DS
Country 3577 0
United Kingdom
Phone 3577 0
+44 (0) 1482 582675
Fax 3577 0
+44 (0) 1482 582172
Email 3577 0
Christopher.Morris@ReckittBenckiser.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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