E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sore throat or acute pharyngitis |
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E.1.1.1 | Medical condition in easily understood language |
Throat inflammation or non bacterial infection |
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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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001002 |
E.1.2 | Term | Acute pharyngitis |
E.1.2 | System Organ Class | 100000004862 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047479 |
E.1.2 | Term | Viral sore throat |
E.1.2 | System Organ Class | 100000004862 |
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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 evaluate and compare the efficacy of MEDICA® (Chlorhexidine Hydrochloride/Lidocaine Hydrochloride) versus placebo from baseline at 2 hours in the management of sore throat and dysphagia in adult patients with non-bacterial pharyngitis. - To evaluate the safety during the study follow-up and at day 7 using a phone call. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate and compare the effect of MEDICA® in throat pain relief at 2 hours after first dose, - To evaluate and compare the efficacy of MEDICA® versus placebo from baseline at Day 4 in the management of sore throat and dysphagia, - To evaluate quality of life as regards sleeping, eating, reading and speaking at each day from day 1 to day 4. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Disease related: - Non-bacterial pharyngitis and/or erythematous sore throat since less than 3 days - Mac Isaac Score < 2 - Negative Rapid Strep Test (RST) - Tonsillopharyngitis Severity Score (TSS) ≥ 5 Population related: - Age over 18 years old - Written informed consent for the study participation |
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E.4 | Principal exclusion criteria |
Disease related: - Presence of peritonsillar or retropharyngeal abscess - Pseudo-membranous pharyngitis - Other causes of dysphagia and/or pharyngitis Treatment related: - Oral, local or injection antibiotic administration within the last 14 days preceding the enrolment - Oral or local steroidal or non-steroidal anti-inflammatory drugs within the last 48 hours preceding the enrolment Population related: - Pregnant women - Breast feeding women - Women in childbearing age not using an effective contraceptive method (hormonal or mechanical) - Inability to comply with the protocol - Linguistic or physiological inability to sign the informed consent form - Participation in a clinical trial during the previous three months |
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E.5 End points |
E.5.1 | Primary end point(s) |
- The comparison between the 2 groups (MEDICA vs. Placebo) in area under the curve (AUC) of sore throat and of dysphagia between T0 and T120 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 hours after the first drug intake |
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E.5.2 | Secondary end point(s) |
- The change from baseline in sore throat relief (using a 7-point scale) at 120 minutes after the first dose. - The comparison between the 2 groups of Day1 to Day 4 for : o The evolution of VAS score as regards sore throat o The evolution of VAS score as regards dysphagia (swallowing troubles) - The comparison of the response to the treatment (as a reduction at D4 by 50% of the TSS baseline score) of the two groups. - Evaluation of quality of life (sleeping, eating, reading, speaking) in patient self-assessment questionnaire - Evaluation of overall acceptability of product by investigator - Assessment of local tolerance by investigator using a 4-point scale - Evaluation of the adverse events reported during the study |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2 hours after the first drug intake and at day 4 |
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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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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 | 10 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |