E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with sore throat |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041367 |
E.1.2 | Term | Sore throat |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to train a UK centre in the 2-stopwatch technique to evaluate the appropriateness of the 2-stopwatch method in the sore throat indication. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
onset of action investigation |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |