Completed

Effects of Two Doses of a Common Cold Treatment on Cognitive Function

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

paracetamol + caffeine

+ paracetamol + caffeine

+ paracetamol

Drug
Who is being recruted

Infections+4

+ Picornaviridae Infections

+ Respiratory Tract Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: November 2011
See protocol details

Summary

Principal SponsorGlaxoSmithKline
Last updated: December 8, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01686646
Principal SponsorGlaxoSmithKline
Last updated: December 8, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

240 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsPicornaviridae InfectionsRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsVirus DiseasesCommon Cold

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
highest dose of Paracetamol and caffeine

Group II

Active Comparator
lowest dose of Paracetamol and caffeine

Group III

Active Comparator
highest dose paracetamol

Group IV

Active Comparator
lowest dose paracetamol

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Common Cold Centre

Cardiff, United KingdomOpen Common Cold Centre in Google Maps
CompletedOne Study Center