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 | 10000938 |
E.1.2 | Term | Acute nasopharyngitis (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 assess the change in alertness level in people suffering from the common cold, 30 minutes following a dose of soluble paracetamol and caffeine compared to soluble paracetamol. This will be assessed from the number of valid responses to the RVIP. |
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E.2.2 | Secondary objectives of the trial |
To assess the change in alertness level in people suffering from the common cold, following a dose of soluble paracetamol and caffeine compared to soluble paracetamol. This will be assessed from the number of valid responses to the RVIP at the 60-minute time point, and the mean valid reaction time at the 30-minute and 60- minute time points. To assess the change in mood in people suffering from the common cold, following a dose of soluble paracetamol and caffeine compared to soluble paracetamol. To assess the change in alertness level in people suffering from the common cold, following a dose of soluble paracetamol and caffeine compared to soluble paracetamol using a sustained and divided attention task. This will be assessed from the number of valid responses to the task, and the mean valid reaction time at the 30-minute and 60-minute time points. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Diagnosis a. Present with symptoms of common cold of no more than 96 hours duration b. Have a self-rating of at least ‘moderate’ for malaise at screening visit c. Have at least 4 other symptoms associated with the common cold |
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E.4 | Principal exclusion criteria |
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 that may affect assessment of mood c. Have a hearing deficit that will prevent them from hearing an auditory signal (hearing aids may be worn).
Medications a. Have used any medication to treat this 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) b. Have taken any menthol containing product in the 2 hours prior to dosing c. Have consumed caffeine (e.g. in tea, coffee, cola or chocolate) in the last 12 hours d. Have used any prescription psychoactive medication (such as, but not limited to, anti-depressants, anxiolytics and anti-psychotics) within 14 days of the study visit. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary timepoint is at 30 minutes post-dosing. The change from baseline in the number of valid responses (from the RVIP) at 30 and 60 minutes will be compared between treatments using analysis of covariance (ANCOVA). |
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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) | 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 | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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
|
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 |