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Creatine

Phase 1

Nutritional Status | Small molecule | Other |GSK plc|Last Updated: Mar 23, 2018

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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02058654A Clinical Study to Investigate the Effects of Creatine Supplementation on Muscle Energetics and Cognitive Function in Young Healthy Male Athletes and an Ageing PopulationPHASE1 COMPLETED 30Dec 1, 2013Jun 24, 2014Mar 23, 20181 United Kingdom
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Study Endpoints
Primary Endpoints
PCr Concentration (at rest)
Baseline to Day 3, 7 and 14

Change in PCr concentration (at rest), as measured by 31P- MRS on the calf. Static MRS will be acquired at rest up to 2 min.

Secondary Endpoints
PCr concentration during recovery
Baseline to Day 3, 7, and 14
Change in PCr from rest to recovery
Baseline to Day 3, 7, and 14
PCr recovery rate (PCr(T1/2))
Baseline to Day 3, 7 and 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Creatine GroupEXPERIMENTALWhey protein (30 g) and creatine supplement (5 g) shaken with 250-300 ml water in a blender bottle, and the full shake to be taken twice a day for 14 days.
Placebo GroupPLACEBO_COMPARATORWhey protein (30 g) and bulking agent powder (5 g) shaken with 250-300 ml water in a blender bottle, and the full shake to be taken twice a day for 14 days.
Interventions
NameTypeDescription
CreatineDRUGCreatine powder (5 g)
PlaceboDRUGBulking agent powder (5 g)
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy volunteer: Group 1: male; Group 2: male or female. * Aged 18-35 years (Group 1), or 50-70 years (Group 2). * Dietary protein intake at or near the current recommended daily amount (0.75 to 0.85 g protein/kg/day). * Participation in regular physical activity (aerobic an...

Countries:United Kingdom
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