Last updated: 11/04/2018 05:47:57
Effect of paracetamol on the common cold
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2010-31-12
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
Common Cold Centre
Cardiff, Wales, United Kingdom, Not Available
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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