E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
upper respiratory illness : 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 compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25 mg and 12.5 mg ketoprofen base) with placebo, on total pain relief summed over 15 to 120 min (TOTPAR15 – 120) after the first intake of study drug. |
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E.2.2 | Secondary objectives of the trial |
To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) with placebo after the first intake on: - the total pain relief summed over 15 to 360min (TOTPAR15-360) - the changes from baseline of global throat pain intensity assessed over 15 to 120min and over 15 to 360min. - the changes from baseline of throat soreness over 15 to 120min and over 15 to 360min - the changes from baseline of swollen throat over 15 to 120min and over 15 to 360min To compare pain relief, global throat pain intensity, throat soreness and swollen throat in the evening of days 1, 2 and 3 To evaluate the safety of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) and placebo at follow-up visit on: Day 4: - adverse events and clinical examination Day 7: - adverse events reporting (followed by a clinical examination if needed)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female patients aged 18 or over, Patients with a sore throat associated or not with a URTI ≥ 24 hours and ≤ 6 days’ duration, in the absence of A.Streptococcus*, Evidence of tonsillo- pharyngitis (TPA score ≥ 5) at inclusion, With a score of throat soreness ≥ 6 (0-10 ordinal scale), With a perception of swollen throat ≥ 60mm (VAS), With a global throat pain intensity such as pain at swallowing assessed by a VAS ≥ 60 mm, Informed consent obtained in writing at the enrolment into the study, Ability to understand and comply with study protocol.
*Specific exploration at Inclusion: - The Score of Mac Isaac will be performed by the investigator. - Presence of streptococcus will be assessed by a throat swab test Patients having a positive swab test will not be included.
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E.4 | Principal exclusion criteria |
Active gastric or duodenal ulcer Severe liver disease Severe kidney disease Women known to be pregnant ≥ 6months Breastfeeding women Any oral surgery or dental extraction within one week prior to the inclusion and during study treatment Any oropharyngeal acute disease that needs an intervention without any delay. Any mouth ulcer, gingivitis or periodontitis with a high risk of haemorrages Any patients having participated to this or another clinical trial within the previous 30 days. Patients having used any local medication containing a local oral anesthetic such as lozenge, spray, mouth rinse or any topical throat treatment within 2 hours before study entry Patients with positive throat swab test for A.Streptococcus pharyngitis Patients having used analgesics within 4 hours before study entry Patients having used any long-acting or slow release analgesics within 12 hours before study entry Patients having used any anti inflammatory treatment 8-12 hours before study entry Patients having used any anti histaminic 8-12 hours before study entry Patients with pharyngeal paresthesia Patients with pharyngeal mycosis Patients with known history of ketoprofen, aspirin or other NSAID-induced bronchospasm Hypersensitivity to ketoprofen or its excipients Any disease that could compromise breathing such as bronchopneumonia or asthma Evidence of mouth-breathing or uncomfortable coughing Any chronic disease that requires a long period anti-inflammatory treatment Any chronic disease that requires long term use of anticoagulants or use of anticoagulants or anti-platelet agents one week before study entry
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E.5 End points |
E.5.1 | Primary end point(s) |
The Intent To Treat (ITT) population will be the primary population used for the primary endpoint analysis. |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |