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Effects of a Common Cold Treatment on Cognitive Function

NCT ID: NCT01466348

Last Updated: 2013-11-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Common Cold

Keywords

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Paracetomol Caffeine Common cold

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Paracetamol and Caffeine

Paracetamol and caffeine

Group Type EXPERIMENTAL

Paracetamol and Caffeine

Intervention Type DRUG

Paracetamol 1000 mg and caffeine 130 mg

Paracetamol

Paracetamol

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

Paracetamol 1000 mg

Interventions

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Paracetamol and Caffeine

Paracetamol 1000 mg and caffeine 130 mg

Intervention Type DRUG

Paracetamol

Paracetamol 1000 mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Common Cold Centre

Cardiff, Wales, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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C6930943

Identifier Type: -

Identifier Source: org_study_id