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Jincaopian

Phase 3

Chronic Pelvic Pain | Small molecule | Pain |Co-Diagnostics, Inc.|Last Updated: Oct 17, 2024

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 Enrollment414
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05970783A Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory DiseasePHASE3 RECRUITING 414Nov 8, 2022Apr 1, 2025Oct 17, 20241 China
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Study Endpoints
Primary Endpoints
Pain disappearance rate after 12 weeks of treatment
12 Weeks

The pain disappearance referred to the Visual Analogue Scale (VAS) score becoming 0-1 points, and was no longer greater than or equal to 2 points at any subsequent evaluation. The pain disappearance rate was defined as the proportion of patients who achieved a pain disappearance after treatment.

Secondary Endpoints
Pain disappearance rate after 4 and 8 weeks of treatment
8 Weeks
Change of weekly average Visual Analogue Scale (VAS) score from baseline after 12 weeks of treatment
12 Weeks
The area under the VAS score-time curve
12 Weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Jincaopian Tablets groupEXPERIMENTALPatients receive Jincaopian Tablets 0.6g/day for 12 weeks.
Placebo groupPLACEBO_COMPARATORPatients receive a placebo 0.6g/day for 12 weeks.
Interventions
NameTypeDescription
Jincaopian TabletsDRUGJincaopian Tablets 0.2g tid p.o.
PlaceboOTHERPlacebo 0.2g tid p.o.
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Eligibility Criteria
Age Range18 Years — 50 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Meet the diagnostic criteria for chronic pelvic pain sequelae of pelvic inflammatory disease; * The average VAS score of pain in the week before enrollment is ≥4; * The McCormack scale of physical signs at the time of enrollment is 4 to 12 points (including 4 points and 12 poi...

Countries:China
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