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Omeprazole

Phase 3

GERD | Small molecule | Gastrointestinal |AstraZeneca PLC|Last Updated: Nov 25, 2013

Target and mechanism

ModalitySmall molecule

Also known as Omeprazole IV

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment219

FDA Designations

No designations recorded

Clinical trial landscape

Omeprazole · 4 trials · 3 indications

Phase 3 3Phase 1 1
NCT00259051A Study to Investigate the Pharmacodynamic Effect After Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese PopulationNon-erosive Reflux Disease
COMPLETED40 Analytics
NCT00259077Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese PopulationNon-erosive Reflux Disease
COMPLETED270 Analytics
NCT00256737Sopran - Omeprazole Treatment Versus SurgeryGERD
COMPLETED219 Analytics
PHASE3COMPLETED
A Study to Investigate the Pharmacodynamic Effect After Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population
Non-erosive Reflux Disease
NCT0025905140
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PHASE3COMPLETED
Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population
Non-erosive Reflux Disease
NCT00259077270
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PHASE3COMPLETED
Sopran - Omeprazole Treatment Versus Surgery
GERD
NCT00256737219
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Study Endpoints

Primary Endpoints

To investigate the pharmacodynamic effect of omeprazole 10mg and 20mg od in patients with NERD, by assessment of the change of the percentage of time with intra-esophageal pH <4 during 24 hours.
To determine the efficacy of omeoprazole 20mg and omeprazole 10mg by assessment of complete resolution rate of heartburn during the fourth week of treatment.
Determine the safety of omeprazole during long term treatment
Bioequivalence of omeprazole 20-mg aqueous-solvent based capsules versus omeprazole 20-mg organic solvent based capsules
predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.

AUC

Bioequivalence of omeprazole 40-mg aqueous-solvent based capsules versus omeprazole 40-mg organic solvent based capsules
predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, and 10 hours postdose.

AUC

Secondary Endpoints

To investigate the relation between pharmacodynamic effect and GERD symptoms,to investigate safety
Complete resolution of heartburn during the first and second week of treatment, assessment of sufficient relief rates of heartburn, assessment of nocturnal heartburn, assessment of other GERD symptoms.
To investigate the long term control of reflux symptoms, healing of esophagitis and persistence of post fundoplication symptoms during long term treatment of omeprazole
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Omeprazole 20mg aqueousACTIVE_COMPARATORTreatment A: a single oral dose of omeprazole 20-mg aqueous-solvent based capsules (AstraZeneca - test)
Omeprazole 20mg organicACTIVE_COMPARATORTreatment B: a single oral dose of omeprazole 20-mg organic-solvent based capsules (Merck - reference for Treatment A)
Omeprazole 40mg aqueousACTIVE_COMPARATORTreatment C: a single dose of omeprazole 40-mg aqueous-solvent based capsules (AstraZeneca - test)
Omeprazole 40mg organicACTIVE_COMPARATORTreatment D: a single dose of omeprazole 40-mg organic-solvent based capsules (Merck - reference for Treatment C)

Interventions

NameTypeDescription
OmeprazoleDRUG -
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Patients who identified their predominant symptom as heartburn and were classifiend as Grande M or N according to Hoshihara's modofied version of Los Angeles Classification at esophagogastroduodenoscopy. Written informed consent, ability to comply with study instructions Excl...

Countries:JapanDenmarkFinlandNorwaySwedenUnited States
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Competitive Landscape -GERD 4 trials

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN1PHASE3Nexium
Catalyst Pharmaceuticals, Inc.CPRX1PHASE2MHS-1031
Phathom Pharmaceuticals, Inc.PHAT1 - Vonoprazan
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