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Cimetidine

Phase 3

Upper Gastrointestinal Bleeding | Small molecule | Gastrointestinal |Bausch Health Companies Inc.|Last Updated: Nov 25, 2019

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment354
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00045799Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically IllPHASE3 COMPLETED 354May 1, 2002May 1, 2003Nov 25, 201958 United States
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Omeprazole sodium bicarbonate immediate release PWD/FSEXPERIMENTAL -
Cimetidine IVACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Omeprazole sodium bicarbonate immediate release PWD/FSDRUG -
Cimetidine IVDRUG -
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Eligibility Criteria
Age Range16 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites58

Patients will be included in the trial if they meet all of the following criteria: 1. An adult or adolescent (greater than or equal to 16 years of age) male or non-pregnant female requiring mechanical ventilation for greater than or equal to 48 hours. 2. An anticipated ICU stay of greater than or e...

Countries:United States
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