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.
1 other identifier
interventional
200
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 12, 2011
CompletedFirst Posted
Study publicly available on registry
January 14, 2011
CompletedResults Posted
Study results publicly available
February 18, 2015
CompletedFebruary 18, 2015
June 1, 2013
2 months
January 12, 2011
June 27, 2013
February 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Breathing Scores Post 15 Minutes
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.
Baseline to 15 minutes
Secondary Outcomes (5)
Breathing Score Post 60 Minutes
Baseline to 60 minutes
Cold Symptoms Score Post 15 Minutes
Baseline to 15 minutes
Cold Symptoms Score Post 60 Minutes
Baseline to 60 minutes
Soothing Attribute Scores
Baseline to 15 and 60 minutes
Overall Cold Symptoms Score
Baseline to 15 and 60 minutes
Study Arms (2)
Paracetamol hot drink
ACTIVE COMPARATORHot drink containing paracetamol
Paracetamol tablets
ACTIVE COMPARATORParacetamol tablets
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
Common Cold Centre
Cardiff, Wales, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2011
First Posted
January 14, 2011
Study Start
October 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
February 18, 2015
Results First Posted
February 18, 2015
Record last verified: 2013-06