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Effects of Two Doses of a Common Cold Treatment on Alertness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01686646
First received: September 13, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Common Cold
 Drug: paracetamol + caffeine
Drug: paracetamol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Two Doses of a Common Cold Treatment on Cognitive Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of correct responses to Rapid Visual Information Processing (RVIP) [ Time Frame: 60 minutes post dose ] [ Designated as safety issue: No ]
    assess the change in alertness level in people suffering from the common cold following paracetamol and caffeine compared to paracetamol alone


Secondary Outcome Measures:
  • mean time of accurate responses on the RVIP [ Time Frame: 120 minutes post dose ] [ Designated as safety issue: No ]
    assess the change in alertness level in people suffering from the common cold, following paracetamol and caffeine compared to paracetamol

  • Number of correct responses to sustained and divided attention task [ Time Frame: 120 minutes post dose ] [ Designated as safety issue: No ]
    assess the change in alertness level using the number of accurate responses to the task, and the mean time of accurate response

  • Number of correct responses to RVIP [ Time Frame: 120 minutes post dose ] [ Designated as safety issue: No ]
    assess the change in alertness level in people suffering from the common cold, following paracetamol and caffeine compared to paracetamol


Enrollment: 240
Study Start Date: November 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: highest dose Paracetamol + caffeine
highest dose of Paracetamol and caffeine
 Drug: paracetamol + caffeine
paracetamol with caffeine
Active Comparator: low-dose Paracetamol + caffeine
lowest dose of Paracetamol and caffeine
 Drug: paracetamol + caffeine
paracetamol with caffeine
Active Comparator: high dose paracetamol
highest dose paracetamol
 Drug: paracetamol
paracetamol
Active Comparator: low dose paracetamol
lowest dose paracetamol
 Drug: paracetamol
paracetamol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686646

Locations
United Kingdom
Common Cold Centre
Cardiff, Wales, United Kingdom
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01686646     History of Changes
Other Study ID Numbers: RH01361
Study First Received: September 13, 2012
Last Updated: December 19, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
alertness

Additional relevant MeSH terms:
Common Cold
Respiratory Tract Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection
Acetaminophen
Caffeine
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 16, 2013