Last updated: 11/04/2018 05:47:57

Effect of paracetamol on the common cold

GSK study ID
C7100991
See study documents
Clinicaltrials.gov ID
NCT01277081
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: To Assess the Subjective Effect of Two Paracetamol Preparations on the Feeling of Breathing in Subjects with the Common Cold.
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Breathing Scores post 15 minutes

Timeframe: Baseline to 15 minutes

Secondary outcomes:

Breathing Score post 60 minutes

Timeframe: Baseline to 60 minutes

Cold Symptoms Score post 15 minutes

Timeframe: Baseline to 15 minutes

Cold Symptoms score post 60 minutes

Timeframe: Baseline to 60 minutes

Soothing Attribute Scores

Timeframe: Baseline to 15 and 60 minutes

Overall Cold Symptoms Score

Timeframe: Baseline to 15 and 60 minutes

Interventions:
  • Drug: Paracetamol hot drink
  • Drug: Paracetamol tablets
    • Enrollment:
    200
    Primary completion date:
    2010-31-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Common cold
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    October 2010 to December 2010
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion Criteria:
    • Symptoms of the common cold of no more than 120 hours duration
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    Common Cold Centre
    Cardiff, Wales, United Kingdom, Not Available
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2010-31-12
    Actual study completion date
    2010-31-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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