Effects of a Common Cold Treatment on Cognitive Function

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Common Cold

Treatments: Drug: Paracetamol and Caffeine; Drug: Paracetamol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01466348

C6930943

Details and patient eligibility

About

A reduction in alertness and lower levels of performance are commonly associated with the common cold. Paracetamol has been shown to be more effective than placebo in treating symptoms associated with upper respiratory tract infection; caffeine has been shown to increase levels of alertness and improve performance of people suffering from colds. This study will investigate any improvement in alertness and performance based on cognitive function and mood assessment in subjects suffering from the common cold, when taking a novel paracetamol and caffeine combination verses paracetamol alone.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Present with symptoms of the common cold of no more than 96 hours duration
• Score of "2" or more on a self-rating for malaise and at least 4 other cold symptoms

Exclusion criteria

• Pregnancy or lactation
• Hypersensitivity to drugs
• Have taken caffeine in the last 12 hours or treated their cold

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Paracetamol and Caffeine

Experimental group

Description:

Paracetamol and caffeine

Treatment:

Drug: Paracetamol and Caffeine

Paracetamol

Active Comparator group

Description:

Paracetamol

Treatment:

Drug: Paracetamol