Common cold MedDRA version: 12.1 Level: LLT Classification code 10000938 Term: Acute nasopharyngitis (common cold)
Conditions
Interventions
Trade Name: Beechams Active Cold Relief Effervescent Tablets
Product Name: Paracetamol/Caffeine Effervescent Tablets
Pharmaceutical Form: Effervescent tablet
Trade Name: Panadol 1000mg Sobres Eferves
Sponsors
GlaxoSmithKline Consumer Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).;Main Objective: 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.;Secondary Objective: 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. | — |
Countries
United Kingdom
Outcome results
None listed