E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010106 |
E.1.2 | Term | Common cold |
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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 subjectively assess the feeling of breathing in people suffering from the common cold over a 15 minute period, following a dose of a mentholated paracetamol hot drink compared to baseline. |
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E.2.2 | Secondary objectives of the trial |
To subjectively assess the feeling of breathing in people suffering from the common cold over a 15 minute period, following a dose of a mentholated paracetamol hot drink compared to a single dose of paracetamol. To subjectively assess the feeling of breathing in people suffering from the common cold over a 60 minute period, following a dose of a mentholated paracetamol hot drink compared to baseline and to a single dose of paracetamol. To subjectively assess the relief of symptoms of common cold other than breathing difficulty in people suffering from the common cold over a 15 and 60 minute period, following a dose of a mentholated paracetamol hot drink compared to baseline and to a single dose of paracetamol.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age Aged at least 18 years.
2. Consent Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
3. Diagnosis at screening a.Present no more than 120 hours ( 5 days) since first symptoms of common cold occur. b.Have a self-rating of at least ‘moderate’ for nasal congestion at screening visit and a minimum of '2' on at least two of the VRS scales' (one of which must be blocked nose). c.Have at least 4 symptoms associated with the common cold and flu
4. Compliance Understands and is willing, able and likely to comply with all study procedures and restrictions.
5. General Health Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
6. Contraception Females of childbearing potential who are in the opinion of the investigator, practising a reliable method of contraception.
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E.4 | Principal exclusion criteria |
1. Pregnancy Women who are known to be pregnant, or who have a positive pregnancy test.
2. Breast-feeding Women who are breast- feeding.
3. Disease a)Have a history of perennial allergic rhinitis or other chronic respiratory disease that (in the opinion of the investigator) is clinically significant. b)Have a history of psychiatric illness (including psychiatric and neurological conditions) that may affect assessments.
4. Medications a.Have used any medication to treat their cold (antibiotics in the last 7 days, antihistamine in the last 72 hours, analgesics or antipyretics in the last 24 hours, decongestant in the last 12 hours, antitussive, medicated lozenge or throat spray in the last 8 hours) prior to screening. b.Have taken any menthol containing product in the 2 hours before screening
5.Alcohol Have consumed alcohol in the last 6 hours prior to screening.
6. Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
7. Clinical Study/Experimental Medication a)Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. b)Previous treatment in this study.
8. Personnel An employee of the sponsor or the study site or members of their immediate family.
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E.5 End points |
E.5.1 | Primary end point(s) |
The following statements will be presented:
1. My breathing feels easy 2. My head feels clear 3. I feel my airways are open 4. I feel soothing in my throat 5. I feel a cooling sensation in my nose 6. I feel my cough is being soothed 7. I can feel the air flowing to my lungs easily 8. My nose feels less blocked 9. I feel my breathing is comfortable 10. The hot drink is soothing (post drink only) 11. Overall, my cold symptoms are improved (post drink only)
Each statement will be followed by the 5 point (0-4) rating scale with ‘0’ being labeled as ‘strongly disagree’ and ‘4’ being labeled as ‘strongly agree’.
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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 |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 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) | 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 Subject, Last Visit. |
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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 | 4 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |