Recent Updates
Recently added Catalysts

Ropivacaine

Phase 3

Anesthesia,Spinal | Small molecule | Pain |AstraZeneca PLC|Last Updated: Mar 26, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment220
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00358280Ropivacaine Versus Bupivacaine for Spinal Anaesthesia in Patients Undergoing Unilateral Lower Limb SurgeryPHASE3 COMPLETED 220 — — Apr 1, 2006Sep 1, 2006Mar 26, 20095 China
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To compare the efficacy, duration of motor block until return to normal function in the non-operated leg after the start of injection, of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml when used for spinal anaesthesia in patients undergoing unilateral lower
Secondary Endpoints
To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in the duration of sensory block at dermatome T10 level
To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in the onset time of sensory block and motor block respectively
To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in the quality of anaesthesia
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
RopivacaineDRUG -
BupivacaineDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Provision of written informed consent * Men or women, 18 years £ age £ 70 years * Patient scheduled for unilateral lower limb surgery with an estimated duration \< 2 hours under spinal anaesthesia * ASA category I \~ II * 18.5 ≤ BMI ≤ 23.9 Exclusion Criteria: * Contraindicat...

Countries:China
Unlock Eligibility Criteria