Common cold MedDRA version: 14.0 Level: LLT Classification code 10000938 Term: Acute nasopharyngitis (common cold) System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Beechams Active Cold Relief Effervescent Tablets
Product Name: Paracetamol/Caffeine Effervescent Tablets
Pharmaceutical Form: Effervescent tablet
INN or Proposed INN: PARACETAMOL
CAS Numbe
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 prior to the screening visit. b) On the cold symptoms evaluation have a self-rating of at least “2” for malaise at Visit 1 c) On the cold symptoms evaluation have at least 4 other symptoms associated with the common cold prior to the treatment visit 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 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
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) at Visit 1. b) Have taken any menthol containing product in the last 2 hours at Visit 1. c) Have consumed caffeine (e.g. in tea, coffee, cola or chocolate) in the last 12 hours at Visit 1. d) Have used any prescription psychoactive medication (such as, but not limited to, anti-depressants, anxiolytics and anti-psychotics) within 14 days of the screening visit. Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. Pregnancy Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. Breast-feeding Women who are breast–feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the change in alertness level in people suffering from the common cold, 60 minutes following paracetamol 1000 milligram (mg) and caffeine 130 mg compared to paracetamol 1000 mg. This will be assessed using the number of accurate responses to the Rapid Visual Information Processing (RVIP). To assess the change in alertness level in people suffering from the common cold, 60 minutes following paracetamol 500 mg and caffeine 65 mg compared to paracetamol 500 mg. This will be assessed using the number of accurate responses to the RVIP.;Secondary Objective: To assess the change in alertness level 120 minutes following paracetamol/caffeine 1000 mg/ 130 mg and 500 mg/65 mg compared to paracetamol 1000 mg and 500 mg respectively. This will be assessed using the number of accurate responses to the RVIP and the mean time of accurate responses on the RVIP task at the 60- minute and 120- minute time points. To assess the change in alertness level following a dose of paracetamol/caffeine 1000 mg/130 mg and 500 mg/65 mg compared to paracetamol 1000 mg and 500 mg respectively, using a sustained and divided attention task. This will be assessed using the number of accurate responses to the task, and the mean time of accurate response at the 60- minute and 120- minute time points. Other secondary endpoints are detailed in the protocol.;Primary end point(s): The change from baseline in the number of accurate responses (from the RVIP) at 60 minutes will be compared between treatments. Paracetamol 1000 mg and caffeine 130 mg vs. paracetamol 1000 mg. Paracetamol 500 mg and caffeine 65 mg vs. paracetamol 500 mg.;Timepoint(s) of evaluation of this end point: The primary timepoint is at 60 minutes post-dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The comparison of 1000 mg paracetamol + 130 mg caffeine vs. 500 mg paracetamol + 65 mg caffeine is a secondary objective and will only be performed if each of the 2-tablet and 1-tablet active doses has demonstrated superiority against their corresponding control groups. From the RVIP, ? The number of accurate responses at 120 minutes. ? The mean time of accurate responses in milliseconds. ? The number of inaccurate responses. ? The number of missed responses. From the sustained and divided attention, this test consists of two tasks: Sustained auditory attention task and the divided attention task. For each task, the following endpoints will be analysed: ? The number of accurate responses. ? The mean time of accurate responses in milliseconds. ? The number of inaccurate responses. ? The number of missed responses. Assessment of mood from the Mood, Alertness and Physical Sensations Scales (MAPSS);Timepoint(s) of evaluation of this end point: 60 and 120 minutes. | — |
Countries
United Kingdom
Contacts
Public ContactSenior Regulatory Affairs Manager
GlaxoSmithKline Consumer Healthcare
Outcome results
None listed