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Medical Food Supplement, standard hospital food

Phase 3

Hip Fracture | Unknown | Musculoskeletal |Abbott Laboratories|Last Updated: Apr 4, 2011

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment127
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01011608Effect of a Medical Food Supplement in Hospitalized Patients Recovering From SurgeryPHASE3 COMPLETED 127Nov 1, 2009Sep 1, 2010Apr 4, 201111 Russia
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Study Endpoints
Primary Endpoints
Blood chemistry
28 days
Secondary Endpoints
Product intake
28 days
Functionality (pain, mobility, strength)
28 days
Surgical site status
28 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Medical Food SupplementEXPERIMENTALMedical food supplement to be given in divided portions in morning, afternoon and evening
standard hospital foodACTIVE_COMPARATORstandard hospital diet
Interventions
NameTypeDescription
Medical Food SupplementOTHERMedical Food Supplement to be given in divided portions in morning, afternoon and evening
standard hospital foodOTHERstandard hospital diet ad. lib.
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Eligibility Criteria
Age Range45 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Subject is \> 45 years of age. * Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. * Subject plans to undergo hip fracture surgery. * Subject has anticipated length of hospital stay of at least 4 weeks. Subject is ...

Countries:Russia
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Competitive Landscape -Fractures 35 trials