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Remifentanil

Phase 1

Pain | Small molecule | Pain |GSK plc|Last Updated: Nov 11, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02602002Experimental Medicine Study to Validate Pharmacodynamic Pain Assessments in Healthy Volunteers With an Opioid Analgesic (Remifentanil)PHASE1 COMPLETED 20 — — Apr 1, 2008Jun 1, 2008Nov 11, 20151 South Korea
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Study Endpoints
Primary Endpoints
To measure the Heat Pain Threshold of a marketed opioid analgesic versus placebo on quantitative experimental pharmacodynamic pain markers.
pre-dose to 67 mins

Heat pain threshold

Secondary Endpoints
To measure the Mechanical Pain Threshold of a marketed opioid analgesic versus placebo. on quantitative experimental pharmacodynamic pain markers.
Change from Baseline (pre-dose) in mechanical pain thresholds measurements at 46 minutes
To measure the Pressure Pain Threshold of a marketed opioid analgesic versus placebo on quantitative pharmacodynamic experimental pain markers.
Change from Baseline (pre-dose) in mechanical pain thresholds measurements at 46mins
To measure the Mood and Alertness of a marketed opioid analgesic versus placebo on alertness on quantitative pharmacodynamic experimental pain markers.
Change from Baseline (Pre-dose) in pressure pain thresholds and tolerance measurements at 46mins, 67 minutes
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
ActiveEXPERIMENTALRemifentanil 0.1 ug/kg/min to 0.10 ug/kg/min
PlaceboPLACEBO_COMPARATORSaline (0.9%)
Interventions
NameTypeDescription
RemifentanilDRUGIV
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range20 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Non-smoking, healthy adult male, aged 20-45 years inclusive. * Body weight \>50 Kg and BMI within the range 18.5-29.9 Kg/m2 inclusive * Healthy as judged by a responsible physician. No clinically significant abnormality identified on the medical or laboratory evaluation. A sub...

Countries:South Korea
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