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Effects of Two Doses of a Common Cold Treatment on Alertness

NCT ID: NCT01686646

Last Updated: 2014-12-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-11-30

Brief Summary

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This study will investigate any improvement in alertness and performance based on cognitive function and mood assessment in subjects suffering 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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alertness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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highest dose Paracetamol + caffeine

highest dose of Paracetamol and caffeine

Group Type ACTIVE_COMPARATOR

paracetamol + caffeine

Intervention Type DRUG

paracetamol with caffeine

low-dose Paracetamol + caffeine

lowest dose of Paracetamol and caffeine

Group Type ACTIVE_COMPARATOR

paracetamol + caffeine

Intervention Type DRUG

paracetamol with caffeine

high dose paracetamol

highest dose paracetamol

Group Type ACTIVE_COMPARATOR

paracetamol

Intervention Type DRUG

paracetamol

low dose paracetamol

lowest dose paracetamol

Group Type ACTIVE_COMPARATOR

paracetamol

Intervention Type DRUG

paracetamol

Interventions

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paracetamol + caffeine

paracetamol with caffeine

Intervention Type DRUG

paracetamol

paracetamol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants with symptoms of cold \< 96 hours, rating of at least '2' on malaise at least 4 other symptoms of cold.
* No history of clinically significant perennial rhinitis, no recent antibiotic, antihistamine or cold treatment, no caffeine in the previous 12 hours, no psychoactive medication in the 14 days prior to screening, no pregnancy, breastfeeding or participation in this trial, or another trial in the 30 days prior to screening.
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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RH01361

Identifier Type: -

Identifier Source: org_study_id