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Omeprazole bicarbonate immediate release PWD/FS

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment354

FDA Designations

No designations recorded

Clinical trial landscape

Omeprazole bicarbonate immediate release PWD/FS · 1 trial · 1 indication

Phase 3 1
NCT00045799Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically IllUpper Gastrointestinal Bleeding
COMPLETED354 Analytics
PHASE3COMPLETED
Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill
Upper Gastrointestinal Bleeding
NCT00045799354
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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 to 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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