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
Results First Received: June 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Common Cold
Interventions: Drug: Paracetamol and Caffeine
Drug: Paracetamol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at the clinical site.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 75 participants were screened, and 72 were randomized. 3 participants did not meet the study criterion. A 5 hour washout period was maintained between treatment periods.

Reporting Groups
  Description
Paracetamol/ Caffeine Tablet Then Paracetamol Powder Participants were orally administered with 200 millilitre (mL) solution of two soluble tablets, [each tablet containing 500 milligram (mg) paracetamol and 65 mg of caffeine], then 200 mL solution of paracetamol soluble powder (1000 mg). A washout period of 5 hours was maintained.
Paracetamol Powder Then Paracetamol/ Caffeine Tablet Participants were orally administered with 200 mL solution of paracetamol soluble powder (1000 mg), then 200 mL solution of two soluble tablets [each tablet containing 500 mg paracetamol and 65 mg of caffeine]. A washout period of 5 hours was maintained.

Participant Flow for 2 periods

Period 1:   Period I - First Intervention
    Paracetamol/ Caffeine Tablet Then Paracetamol Powder     Paracetamol Powder Then Paracetamol/ Caffeine Tablet  
STARTED     36     36  
Intent To Treat (ITT) Population     36     35 [1]
COMPLETED     36     35  
NOT COMPLETED     0     1  
Withdrawal by Subject                 0                 1  
[1] 1 participant withdrew prior receiving the treatment

Period 2:   Period II - Second Intervention
    Paracetamol/ Caffeine Tablet Then Paracetamol Powder     Paracetamol Powder Then Paracetamol/ Caffeine Tablet  
STARTED     35     36  
COMPLETED     35     36  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Randomized Participants All randomized participants were evaluated for baseline measures.

Baseline Measures
    All Randomized Participants  
Number of Participants  
[units: participants]
  71  
Age  
[units: Years]
Mean ± Standard Deviation
  20.8  ± 4.19  
Gender  
[units: Participants]
 
Female     47  
Male     24  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Adjusted Mean Change From Baseline in Number of Valid Responses to RVIP Cognitive Test   [ Time Frame: Baseline to 60 minutes post treatment administration ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


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