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Lactated Ringer's

Phase 3

Post-ERCP Acute Pancreatitis | Small molecule | Other |The Cooper Companies, Inc.|Last Updated: Feb 26, 2018

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
UNCONTROLLED
Total Trials1
Total Enrollment192
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02641561Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP PancreatitisPHASE3 COMPLETED 192Oct 1, 2014Jun 1, 2016Feb 26, 2018 -
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Study Design & Arms
Interventions
NameTypeDescription
IndomethacinDRUGIndomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis
Lactated Ringer's SolutionDRUGLactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
Normal SalineDRUGstandard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.
PlaceboDRUGPlacebo would be a suppository 50 mg x 2
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