E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10049140 |
E.1.2 | Term | Pharyngotonsillitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
The primary objective of the study is to compare the analgesic effect of V0498 lozenges versus placebo on the Total Pain Relief (TOTPAR) assessed on a 7-point rating scale called the Sore Throat Relief Scale (STRS) over 120min after the start of sucking of 1st study drug administered |
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E.2.2 | Secondary objectives of the trial |
To compare the analgesic effect of V0498 ibuprofen lozenges versus placebo with the following assessments:
•on the Total Pain Relief (TOTPAR) assessed on a 7-point rating scale called the Sore Throat Relief Scale (STRS) over 15min, 30 min, 45min, 60 min, 90 min after the start of sucking of the 1st study drug administered,.
•on the Sore Throat Pain Intensity Difference (PID) on swallowing from baseline to 30min, 60min, 90min after the start of sucking of the 1st study drug administered, D1 evening, D2, D3 and D4.
•on the Sum of Pain Intensity Differences on swallowing (SPID) from baseline to 30min, 60min, 90min, 120min after the start of sucking of the 1st study drug administered
•on the pain responders rate (reduction of 50% of baseline score) 30min, 60min, 90min,120min after the start of sucking of the 1st study drug administered, D1 evening, D2, D3 and D4
•on the time of onset of the first pain response within the 120min after the start of sucking of the 1st study |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- male or female aged at least 18 years old - patient with an acute sore throat: - of recent onset (within the last 72 hours) - associated or not with an upper respiratory tract infection (URTI) - in the absence of Streptococcus group A (negative Streptococcal swab test before randomisation) - Tonsillo-Pharyngitis Assessment scale (TPA) ≥ 5 on a 21- point scale - Sore Throat Pain Intensity when swallowing (STPIS) ≥ 60 mm on a 100 mm visual analogue scale (VAS) - for female patient with child-bearing potential: negative urinary pregnancy test - patient able to understand and to comply with all study procedures (e.g. such as those who could understand correctly the use of the pain rating scales) - patient having signed a written informed consent
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E.4 | Principal exclusion criteria |
Related to pathologies: - severe respiratory tract infection (pneumonia, bronchitis or laryngitis) - oro-pharyngeal paresthesia or mycosis - severely traumatised and/or very severe oromucosal inflammation - tonsillopharyngectomy - Peritonsillar abscess - hyposalivation or asialia, or any swallowing disorder other than linked to sore throat. - any painful condition that may have distracted attention from sore throat pain, (e.g. mouth ulcers) - any disease that could compromise breathing such as bronchospasm or severe/instable asthma - mouth-breathing or uncomfortable coughing - history of an upper gastrointestinal ulcer within the past 30 days before randomisation - Crohn’s disease or ulcerative colitis - history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. - known cerebrovascular haemorrhage or other haemorrhage disease - severe heart failure - severe renal impairment - severe hepatic failure - disseminated erythematous lupus
Related to treatments: - hypersensitivity to ibuprofen or other NSAIDs (including bronchospasm) or to excipients - long term use (≥ 3 times per week within the last month or regular intake within the last 3 months before randomisation) of anti-inflammatory drugs - any long-acting or slow release analgesic intake including NSAIDs within 24 hours before randomisation (e.g. piroxicam or naproxen) - any anti-inflammatory drugs intake by systemic route within 12 hours before randomisation - any paracetamol intake within 6 hours before randomisation - any cold medication (decongestant, antihistamine, expectorant, antitussive) within 6 hours before randomisation - any topical throat medication intake containing or not a local oral anaesthetic such as lozenge, spray, mouth rinse within 4 hours before randomisation - any product with demulcent properties within 2 hours before randomisation - any antibiotics intake by systemic route within 7 days before randomisation - any intake of anticoagulants or antiplatelet agents within 14 days before randomisation - any intake of anticholinergic drugs, atropine, scopolamine, quaternary ammoniums, imipraminic antidepressives, phenothiazines, neuroleptics, disopyramide or antimitotic drugs which influence salivary flow within 14 days before randomisation
Related to population: - heavy smokers (>20 cigarettes/day) - history of alcohol abuse - patient who is a family member or work associate (secretary, nurse, technician ..) of the investigator - female patient who is in post-partum period or a breast-feeding mother - patient who is participating in or is in the exclusion period of another clinical trial - patient mentally unable in the opinion of the investigator to understand the nature and the objectives of the study and unable to comply fully with the study requirements - patient who has forfeited his freedom by administrative or legal award, or who is under guardianship - patient who does not accept not to take any medications or OTC drugs during the 1 hour before and the 2 hours after the start of sucking of the 1st study drug administered - patient who does not accept not to eat or not to drink or not to smoke during the 1 hour before and the 2 hours after the start of sucking of the 1st study drug administered - patient who does not accept not to smoke or not to eat or not to drink at least 1 hour before each assessment timepoint - pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure of the study is to compare the effect of V0498 lozenges to that of placebo on the Total Pain Relief (TOTPAR) assessed on a 7-point rating scale called the Sore Throat Relief Scale (STRS) over 120min after the start of sucking of 1st study drug administered.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From Baseline to 120 minutes |
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E.5.2 | Secondary end point(s) |
1-TOTal PAin Relief (TOTPAR) 2-Sore Throat Pain Intensity Difference (PID) on swallowing 3-Sum of Pain Intensity Differences on swallowing (SPID) 4-Pain responders rate 5-Time of onset of the first pain response within 120 min 6-Time of onset of the first pain relief within 120 min 7-Global efficacy rating by the patient 8-Investigator’s overall assessment 9-Lozenges consumption
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-over 15min, 30 min, 45min, 60 min, 90 min after the start of sucking of the 1st study drug administered. 2-from baseline to 30 min, 60 min, 90 min after the start of sucking of the 1st study drug administered, Day 1 evening, Day 2, Day 3 and Day 4 3-from baseline to 30min, 60 min, 90 min,120min after the start of sucking of the 1st study drug administered 4-at 30 min, 60 min, 90 min, 120 min after the start of sucking of the 1st study drug administered, D1 evening, D2, D3 and D4 5-Time of onset of the first pain response within the 120 min 6-Time of onset of the first pain relief within the 120 min 7-At 120 min and D1 evening, D2, D3 and D4 8-At 120 min and during the study-end visit (D5) 9-By calendar day from D1 to D4
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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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 | No |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 29 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |