Effects of a Common Cold Treatment on Cognitive Function

NCT01466348 | Completed Phase 4 Results

• 1 other identifier: C6930943
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Common Cold

Keywords

Paracetomol; Caffeine; Common cold

Outcome Measures

Primary Outcomes (1)

• Adjusted Mean Change From Baseline in Number of Valid Responses to Rapid Visual Information Processing (RVIP) Cognitive Test

  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.

  Baseline to 30 minutes post treatment administration

Secondary Outcomes (10)

• Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test

  Baseline to 60 minutes post treatment administration

• Adjusted Mean Change in Baseline in Valid Reaction Time to RVIP Cognitive Test

  Baseline, 30 minutes and up to 60 minutes post treatment administration

• Mean Change From Baseline in Number of Incorrect and Missed Responses to RVIP Cognitive Test

  Baseline, 30 minutes and up to 60 minutes post treatment administration

• Adjusted Mean Change From Baseline in Number of Valid Responses to Sustained Attention Tasks (SAT) Cognitive Test

  Baseline, 30 minutes and up to 60 minutes post treatment administration

• Mean Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test

  Baseline, 30 minutes and up to 60 minutes post treatment administration

Study Arms (2)

Paracetamol and Caffeine

EXPERIMENTAL

Paracetamol and caffeine

Drug: Paracetamol and Caffeine

Paracetamol

ACTIVE COMPARATOR

Paracetamol

Drug: Paracetamol

Interventions

Paracetamol and Caffeine DRUG

Paracetamol 1000 mg and caffeine 130 mg

Paracetamol and Caffeine

Paracetamol DRUG

Paracetamol 1000 mg

Paracetamol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or lactation
• Hypersensitivity to drugs
• Have taken caffeine in the last 12 hours or treated their cold

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Common Cold Centre

Cardiff, Wales, United Kingdom

Location

MeSH Terms

Conditions

Common Cold

Interventions

Acetaminophen; Caffeine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Apparent carryover effect from the paracetamol/ caffeine treatment taken in Period 1 into the baseline assessment of Period 2 was observed, hence the statistical analysis was amended after unblinding the statistician.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 7, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 25, 2013
• Results First Posted: November 25, 2013

Record last verified: 2013-09

Locations

GB (1)