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Paracetamol hot drink

Phase 2

Common Cold | Small molecule | Other |GSK plc|Last Updated: Feb 18, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01277081Effect of Paracetamol on the Common ColdPHASE2 COMPLETED 200Oct 1, 2010Dec 1, 2010Feb 18, 20151 United Kingdom
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Study Endpoints
Primary Endpoints
Breathing Scores Post 15 Minutes
Baseline to 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.

Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Paracetamol hot drinkACTIVE_COMPARATORHot drink containing paracetamol
Paracetamol tabletsACTIVE_COMPARATORParacetamol tablets
Interventions
NameTypeDescription
Paracetamol hot drinkDRUGHot drink containing paracetamol
Paracetamol tabletsDRUGParacetamol tablets
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

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

Countries:United Kingdom
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