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paracetamol + caffeine

Phase 3

Common Cold | Small molecule | Other |GSK plc|Last Updated: Dec 8, 2014

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
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01686646Effects of Two Doses of a Common Cold Treatment on AlertnessPHASE3 COMPLETED 240Nov 1, 2011Nov 1, 2012Dec 8, 20141 United Kingdom
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Study Endpoints
Primary Endpoints
Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test
Baseline to 60 minutes post treatment administration

The RVIP assessed the performance of visual attention mechanisms in remaining vigilant to periodically occurring events. The number of accurate responses to RVIP task was determined from the cognitive function computerised output. Participants monitored a series of single numbers (0-9) appearing in the centre of the screen. During the RVIP task, participants responded to consecutive sequences of three odd or three even numbers by pressing the corresponding response button as quickly and accurately as possible. This was identified in the output file by a value of '1' in 'TARGET=1' column. Also, the response time (in seconds) was recorded in the 'RT' column. If the subject correctly responded to the target, this was identified by a value of '1' in the 'CORRECT=1' column. The number of accurate responses was calculated as the total number of records where 'CORRECT=1' had a value of '1'. The test lasted approximately 9 minutes and number of accurate responses to stimulus was calculated.

Secondary Endpoints
Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test
Baseline to 120 minutes post treatment administration
Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task
Baseline, 60 minutes and upto 120 minutes post treatment administration
Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task
Baseline, 60 minutes and up to 120 minutes post treatment administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
highest dose Paracetamol + caffeineACTIVE_COMPARATORhighest dose of Paracetamol and caffeine
low-dose Paracetamol + caffeineACTIVE_COMPARATORlowest dose of Paracetamol and caffeine
high dose paracetamolACTIVE_COMPARATORhighest dose paracetamol
low dose paracetamolACTIVE_COMPARATORlowest dose paracetamol
Interventions
NameTypeDescription
paracetamol + caffeineDRUGparacetamol with caffeine
paracetamolDRUGparacetamol
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

* Participants with symptoms of cold \< 96 hours, rating of at least '2' on malaise at least 4 other symptoms of cold. * No history of clinically significant perennial rhinitis, no recent antibiotic, antihistamine or cold treatment, no caffeine in the previous 12 hours, no psychoactive medication in...

Countries:United Kingdom
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