Effects of Two Doses of a Common Cold Treatment on Alertness

NCT01686646 | Completed Phase 3 Results

• 1 other identifier: RH01361
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Common Cold

Keywords

alertness

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Number of Accurate 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. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. 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. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.

  Baseline to 60 minutes post treatment administration

Secondary Outcomes (9)

• Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test

  Baseline to 120 minutes post treatment administration

• Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task

  Baseline, 60 minutes and upto 120 minutes post treatment administration

• Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task

  Baseline, 60 minutes and up to 120 minutes post treatment administration

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

  Baseline, 60 minutes and up to 120 minutes post treatment administration

• Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task

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

Study Arms (4)

highest dose Paracetamol + caffeine

ACTIVE COMPARATOR

highest dose of Paracetamol and caffeine

Drug: paracetamol + caffeine

low-dose Paracetamol + caffeine

ACTIVE COMPARATOR

lowest dose of Paracetamol and caffeine

Drug: paracetamol + caffeine

high dose paracetamol

ACTIVE COMPARATOR

highest dose paracetamol

Drug: paracetamol

low dose paracetamol

ACTIVE COMPARATOR

lowest dose paracetamol

Drug: paracetamol

Interventions

paracetamol + caffeine DRUG

paracetamol with caffeine

highest dose Paracetamol + caffeine; low-dose Paracetamol + caffeine

paracetamol DRUG

paracetamol

high dose paracetamol; low dose paracetamol

Eligibility Criteria

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

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

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

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 18, 2012
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 8, 2014
• Results First Posted: July 14, 2014

Record last verified: 2014-07

Locations

GB (1)