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Effect of Paracetamol on the Common Cold

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01277081
First received: January 12, 2011
Last updated: February 2, 2015
Last verified: June 2013

January 12, 2011
February 2, 2015
October 2010
December 2010   (final data collection date for primary outcome measure)
Breathing Scores Post 15 Minutes [ Time Frame: Baseline to 15 minutes ] [ Designated as safety issue: No ]
A mean breathing score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes, derived from participant responses to questions relating to breathing i.e. "my breathing feels easy", "I feel airways are open", "I feel a cooling sensation in my throat", "I can feel the air flowing to my lungs easily", "My nose feels less blocked" and "I feel my breathing is comfortable". The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.
Change from baseline in Visual Rating Scale Scores for Breathing Symptoms [ Time Frame: Baseline to 15 minutes post dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01277081 on ClinicalTrials.gov Archive Site
  • Breathing Score Post 60 Minutes [ Time Frame: Baseline to 60 minutes ] [ Designated as safety issue: No ]
    A mean breathing score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes, derived from participant responses to questions relating to breathing i.e. "my breathing feels easy", "I feel airways are open", "I feel a cooling sensation in my throat", "I can feel the air flowing to my lungs easily", "My nose feels less blocked" and "I feel my breathing is comfortable". The breathing scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.
  • Cold Symptoms Score Post 15 Minutes [ Time Frame: Baseline to 15 minutes ] [ Designated as safety issue: No ]
    A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5 and 15 minutes from participant responses to questions relating to cold symptoms i.e. "My head feels clear", "I feel soothing in my throat" and "I feel my cough is being soothed". The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.
  • Cold Symptoms Score Post 60 Minutes [ Time Frame: Baseline to 60 minutes ] [ Designated as safety issue: No ]
    A mean Cold symptom score was calculated at baseline, 30 seconds, 2, 5, 15 and 60 minutes from participant responses to questions relating to cold symptoms i.e. "My head feels clear", "I feel soothing in my throat" and "I feel my cough is being soothed". The cold symptom scores were rated by the participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'. For each participant, a mean score was derived by summing the responses and dividing by the number of questions answered.
  • Soothing Attribute Scores [ Time Frame: Baseline to 15 and 60 minutes ] [ Designated as safety issue: No ]
    Soothing attribute of test treatment was assessed by asking the question "if the hot drink is soothing" at baseline, 15 and 60 minutes. The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'.
  • Overall Cold Symptoms Score [ Time Frame: Baseline to 15 and 60 minutes ] [ Designated as safety issue: No ]
    Overall cold symptom score was assessed by asking the question "my cold symptoms are improved" only post consuming the drink at baseline, 15 and 60 minutes . The response to the question was rated by participants on a 5 point (0-4) rating scale with '0' being labeled as 'strongly disagree' and '4' being labeled as 'strongly agree'.
  • Change from baseline in Visual Rating Scale Scores for Other Cold Symptoms [ Time Frame: Baseline to 15 minutes post dose ] [ Designated as safety issue: No ]
  • Change from baseline in Visual Rating Scale Scores for Breathing Symptoms [ Time Frame: Baseline to 60 minutes post dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Paracetamol on the Common Cold
To Assess the Subjective Effect of Two Paracetamol Preparations on the Feeling of Breathing in Subjects With the Common Cold.
The aim of this study is to subjectively assess symptoms in subjects suffering from the common cold following a single dose of paracetamol hot drink compared to paracetamol tablet
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Common Cold
  • Drug: Paracetamol hot drink
    Hot drink containing paracetamol
  • Drug: Paracetamol tablets
    Paracetamol tablets
  • Active Comparator: Paracetamol hot drink
    Hot drink containing paracetamol
    Intervention: Drug: Paracetamol hot drink
  • Active Comparator: Paracetamol tablets
    Paracetamol tablets
    Intervention: Drug: Paracetamol tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Symptoms of the common cold of no more than 120 hours duration
  • Self-rating congestion of at least moderate severity
  • Suffering from at least four symptoms of common cold or flu
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01277081
C7100991
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP