Effects of a common cold treatment on cognitive functio

• Conditions: Common cold; MedDRA version: 12.1Level: LLTClassification code 10000938Term: Acute nasopharyngitis (common cold)

• Registration Number: EUCTR2010-022857-41-GB
• Lead Sponsor: GlaxoSmithKline Consumer Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified