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hyaluronate

Phase 3

Osteoarthritis of Shoulder | Small molecule | Musculoskeletal |Sanofi|Last Updated: Jan 11, 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
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment602
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00377624HUPS: Hyalgan Use in Painful ShoulderPHASE3 COMPLETED 602 — — Jan 1, 2002Sep 1, 2004Jan 11, 20111 United States
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Study Endpoints
Primary Endpoints
Improvement in shoulder pain on movement in previous 24 hours, based upon 100 mm VAS score up to 3 months after baseline for the 3 i.a. and 5 i.a. sodium hyaluronate injections compared to PB-Saline control
Secondary Endpoints
Maintenance or improvement from baseline in shoulder pain on movement in previous 24 hours based upon 100 mm VAS score up to 6 months after baseline of
sodium hyaluronate treated patients compared to PB-Saline.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
sodium hyaluronateDRUG -
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Eligibility Criteria
Age Range35 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to po...

Countries:United States
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