Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: July 26, 2012
Last verified: July 2012

January 12, 2011
July 26, 2012
October 2010
December 2010   (final data collection date for primary outcome measure)
Change from baseline in Visual Rating Scale Scores for Breathing Symptoms [ Time Frame: Baseline to 15 minutes post dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01277081 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01277081
C7100991
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2012

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