E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sore throat associated with upper respiratory infections |
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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] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041368 |
E.1.2 | Term | Sore throat NOS |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10068319 |
E.1.2 | Term | Oropharyngeal pain |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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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 assess the parameters of the treatment effect of test product in comparison with comparator product and placebo in subjects with sore throat associated with upper respiratory tract infections.
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E.2.2 | Secondary objectives of the trial |
- To assess the safety profile of test product in comparison with comparator product and placebo
- To evaluate the adequacy of efficacy and safety variables for the application in further studies with the test product |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subjects with a sore throat associated with URTI
• Onset of sore throat ≤ 6 days
• Both sexes, age range 18-65 years
• ≥ 3 points on the 10 point Tonsillopharyngitis assessment (TPA) score
• Moderate to severe sore throat pain defined as a score ≥ 60 mm on the 100 mm Sore Throat Pain Intensity Scale |
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E.4 | Principal exclusion criteria |
• Pregnancy and lactation
• Subjects with any evidence of mouth breathing or coughing which could compromise respiratory function and worsen sore throat
• Severe streptococcal tonsillitis (8 points or more of the TPA and positive rapid antigen detection test)
• Recurrent (chronic) sore throat
• Other severe respiratory tract diseases (pneumonia, infectious mononucleosis, asthma or difficulty in breathing, peritonsillar abscess etc.)
• Oropharyngeal lesions (tumours, purulent necrotic process, aphtous ulcers, etc.)
• Pharmacological therapy with:
- antibiotics,
- oral antiseptics and demulcents in the form of sprays, gargles, lozenges or drops within 3 h before the initial dose,
- short-acting analgesics within 6 hours before the initial dose,
- long-acting or slow-release analgesic within 24 hours before the initial dose,
- local anesthetics within 4 hours before the initial dose,
- antihistamines within 12 hours before the initial dose,
- nasal decongestants, anti-tussives or expectorants including their fixed combinations within 8 hours before the initial dose.
• Any chronic disease which requires long-term use of oral analgesics, NSAIDs, antihistamines and local anesthetics
• Previously diagnosed hypersensitivity to benzydamine, other NSAIDs, cetylpyridinium chloride or any other component of study drugs
• Subject is currently participating in another clinical trial
• Excessive alcohol consumption, drug abuse or drug addiction
• Subject refuses to participate with the investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
Total Pain Relief (TOTPAR 3-180min) assessed by the pain relief score (questionnaire) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1 Percent of maximal Total Pain relief (%max TOTPAR): the ratio between observed TOTPAR 3-180min and the highest possible TOTPAR3-180min score
2 Percent of responders (% RESP): the share of subjects who will reach %max TOTPAR 3-180min of at least 33 %.
3 Sore Throat Pain Relief (STPAR): assessed by sore throat pain relief (STPAR) scale
4 Time to Sore Throat Pain relief (TSTPAR): the time in minutes to at least 1 point increase on the STPAR scale
5 Sore Throat Pain Intensity Differences (STPID 3-180min): calculation of area under curve (AUC) of pain intensity differences with respect to baseline, assessed by visual analogue scale (VAS)
6 Sore Throat Pain Intensity (STPI): assessed by visual analogue scale (VAS)
7 Swollen Throat Differences (STD15-180min): calculation of AUC of symptoms of swollen throat differences with respect to baseline, assessed by VAS
8 Swollen Throat (ST): assessed by VAS
9 Difficulty in swallowing differences (DSD 15-180min): calculation of AUC of swallowing difficulty differences with respect to baseline, assessed by VAS
10 Difficulty in swallowing (DS): assessed by VAS
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Variables 1, 2, 4, 5, 7 and 9:
at 180 min after the IMP application
Variables 3 and 6:
at 3, 6, 9, 12, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165 and 180 min after the IMP application
Variables 8 and 10:
at 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165 and 180 min after the IMP application
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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 | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | No |
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 | 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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |