patients with sore throat MedDRA version: 9.1 Level: LLT Classification code 10041367 Term: Sore throat
Conditions
Interventions
Trade Name: Ibuprofen Caplets 200mg
Pharmaceutical Form: Tablet
INN or Proposed INN: IBUPROFEN
CAS Number: 15687271
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Reckitt Benckiser Healthcare International Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: Patients aged 16 to 65 years of age are eligible to participate. 2) Sex: Both males and females are eligible for entry 3) Primary diagnosis: All patients selected for this study will have a sore throat due to upper respiratory tract infection. In addition they will have a TPA score of = 5 (range 0 – 21), a throat soreness scale of = 6 on the 11-point ordinal scale and a difficulty in swallowing score of = 60 mm on the 100 mm VAS. 4) Patients who have given written informed consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) A history of allergy (including angioedema, urticaria, bronchospasm and rhinitis) related to treatment with ibuprofen, flurbiprofen, aspirin or other NSAIDs or to formulation constituents, eg 2) A history of peptic ulcers, duodenal ulcers, or gastrointestinal bleeding. 3) A history of frequent dyspepsia, heartburn, or indigestion. 4) Inflammatory bowel disease e.g. Crohn’s or ulcerative colitis, chronic/acute hepatic renal or coagulation disorders that might preclude NSAID use. 5) Severe coughing 6) Those who have used any analgesic, antipyretic or “cold” medication (e.g. decongestant, antihistamine, antitussive, or throat lozenge) within the previous 8 hours. 7) Those who have taken any medicated confectionary or products with demulcent properties such as sweets, within the previous 2 hours. 8) Those with any painful condition that may distract attention from sore throat pain e.g. mouth ulcers, etc. 9) Those unable to refrain from smoking during their stay in the research centre. 10) Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. an oral contraceptive, an approved hormonal implant, an intrauterine device or condoms/diaphragm and spermicide). A woman of childbearing 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). 11) Those previously randomised into this study. 12) 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. 13) Those unable, in the opinion of the investigator, to comply fully with the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to train a UK centre in the 2-stopwatch technique to evaluate the appropriateness of the 2-stopwatch method in the sore throat indication.;Secondary Objective: to determine the variability of time to first perceptible relief and time to meaningful relief with a view to designing further studies to investigate the time of onset of relief following dosing with various sore throat treatments. The results from this trial will also assist sample size determination in these further studies.;Primary end point(s): The primary endpoint for this study is the time to first confirmed perceptible sore throat pain relief using the 2-stopwatch method (confirmed perceptible sore throat pain relief is defined as perceptible sore throat pain relief that goes on to become meaningful sore throat pain relief). Each patient will be instructed, “Stop the first stopwatch when you first feel any sore throat pain relief whatsoever. This does not mean you feel completely better, although you might, but when you first feel any relief in the sore throat pain you have now.” This will be analysed via a Cox proportional hazards model with a single factor for treatment group. Patients who do not report confirmed perceptible sore throat pain relief will be censored at the time of their last recorded assessment. | — |
Countries
United Kingdom
Outcome results
None listed