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Eccentric exercise

Phase 1

Tendon Injuries | Unknown | Musculoskeletal |GSK plc|Last Updated: May 15, 2017

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02014662A Methodology Study to Assess Muscle Damage After Eccentric ExercisePHASE1 COMPLETED 12Jan 14, 2014Jul 2, 2014May 15, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Change and percent change in maximal leg isometric strength from the baseline up to three weeks after eccentric exercise
Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22

Muscle strength is a measure the amount of force produced during a maximal voluntary contraction. Strength will be assessed by a maximal isometric (fixed length) contraction.

Secondary Endpoints
Change in peak torque and total work performed over the course of 10 consecutive, maximal isokinetic knee extension and flexion contractions
Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22
Patient pain assessment using a visual analog scale
Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22
Change in degree of motion
Day 1, 2, 3, 4, 6, 8, 11, 17 and Day 22
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Arm 1OTHERHealthy subjects aged 18 to 35 years
Interventions
NameTypeDescription
Eccentric exerciseOTHEREach subject will perform eccentric exercise against a predefined personal maximal strength of their non-dominant leg on day 1. Changes on strength, biomarker concentrations and muscle protein synthesis during damage and recovery will be measured over 22 days.
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Eligibility Criteria
Age Range18 Years — 35 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males aged between 18 and 35 years of age inclusive, at the time of signing the informed consent, not on a regular exercise program. * Body Mass Index (BMI) 18-27 kilogram per meter square (kg/m\^2) with waist circumference \<96 centimeter (cm). * Healthy as determined by a re...

Countries:United Kingdom
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