Effects of a Common Cold Treatment on Cognitive Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01466348
First received: November 3, 2011
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Common Cold
Drug: Paracetamol and Caffeine
Drug: Paracetamol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of a Common Cold Treatment on Cognitive Function

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test [ Time Frame: Baseline to 30 minutes post treatment administration ] [ Designated as safety issue: No ]
    The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.


Secondary Outcome Measures:
  • Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test [ Time Frame: Baseline to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.

  • Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. Mean valid reaction time was determined.

  • Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. The test lasted approximately 9 minutes and mean number of valid responses to stimulus was calculated.

  • Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated.

  • Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated.

  • Adjusted Mean Change From Baseline in Valid Reaction Time to SAT Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    Auditory and visual attention of participants was evaluated using a validated Sustained Attention task. For the sustained visual attention task, participants were required to respond to the letter 's' every time it appears in a continuous stream of letters presented on a screen. For the sustained auditory attention task, participants responded to the number '8' every time it appears in a continuous stream of numbers presented through headphones. Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated.

  • Adjusted Mean Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of valid responses to visual and auditory tests were calculated.

  • Adjusted Mean Change From Baseline in Valid Reaction Time to DAT Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of valid reaction time to visual and auditory tests were calculated.

  • Mean Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    For the DAT Cognitive test, auditory and visual stimuli were simultaneously presented and participants were asked to respond to occurrences of 's' (visual) or '8' (auditory). Total test duration was approximately 6 minutes. Mean values of incorrect and missed responses to visual and auditory tests were calculated.

  • Adjusted Mean Change From Baseline in Mood Alertness and Physical Sensation Scales (MAPSS) Cognitive Test [ Time Frame: Baseline, 30 minutes and up to 60 minutes post treatment administration ] [ Designated as safety issue: No ]
    Mood patterns was evaluated using the Mood, Alertness and Physical Sensation Scales (MAPSS) which comprised of 23 questions describing moods and physical sensations, on a 9-point scale anchored at the left hand end with 'not at all' and the right hand end with 'extremely'. For each question, '9' represented the 'best' score and '1' represented the 'worst' score. Mean score was calculated by summing the responses and dividing by the number of questions answered. MAPSS Questionnaire was further divided into three main clusters: Alertness; Anxiety and Headache as per the questions.


Enrollment: 72
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paracetamol and Caffeine
Paracetamol and caffeine
Drug: Paracetamol and Caffeine
Paracetamol 1000 mg and caffeine 130 mg
Active Comparator: Paracetamol
Paracetamol
Drug: Paracetamol
Paracetamol 1000 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466348

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: NCT01466348     History of Changes
Other Study ID Numbers: C6930943
Study First Received: November 3, 2011
Results First Received: June 27, 2013
Last Updated: September 25, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Paracetomol
Caffeine
Common cold

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Acetaminophen
Caffeine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
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 August 19, 2014