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Omeprazole

Phase 4FDA approved

GERD | Small molecule | Gastrointestinal |AstraZeneca PLC|Trials Updated: Jan 24, 2011

Omeprazole development status

FDA approval on record Jun 15, 2004
Approval holderSalix
ApplicationNDA021636
Highest phase Phase 4 (NCT00641264)
Phase scored for AZNPhase 3
Registered trials 104 across 48 sponsors since Sep 2005

Label indication Omeprazole and Sodium Bicarbonate for oral suspension and Omeprazole and Sodium Bicarbonate capsules are indicated in adults for the : short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. short-term treatment (4 to 8 weeks) of active benign gastric ulcer. FDA label

Omeprazole target and mechanism

Molecular targetATP4A, ATP4B
Target classInhibitor
ModalitySmall molecule

Also known as Omeprazole IV

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials3
Total Enrollment529

FDA Designations

No designations recorded

Omeprazole clinical trials

Omeprazole · 3 trials · 2 indications

Phase 3 3
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 DiseaseUnlock trial analytics
PHASE3COMPLETED
Four-week Omeprazole Treatment of Non-erosive Reflux Disease in a Japanese Population
Non-erosive Reflux DiseaseUnlock trial analytics
PHASE3COMPLETED
Sopran - Omeprazole Treatment Versus Surgery
GERDUnlock trial analytics

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

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

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:JapanDenmarkFinlandNorwaySweden
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Competitive Landscape -GERD 11 trials

Top 1 of 5 competitors

CompanyTickerTrialsLead PhaseDrugs
Phathom Pharmaceuticals, Inc.PHAT2PHASE3Vonoprazan
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Frequently asked questions about Omeprazole

What is Omeprazole used for?

Omeprazole is used to treat gastroesophageal reflux disease (GERD) and non-erosive reflux disease. It is a small molecule developed by AstraZeneca PLC (ticker: AZN) and has been studied in Phase 3 clinical trials for these gastrointestinal conditions.

What does Omeprazole target?

Omeprazole targets ATP4A and ATP4B, which are subunits of the gastric proton pump. It acts as an inhibitor of this target, reducing gastric acid secretion. This mechanism underlies its use in acid-related gastrointestinal disorders such as GERD and non-erosive reflux disease.

Who makes Omeprazole?

Omeprazole is developed by AstraZeneca PLC, which trades under the ticker AZN. The company has conducted Phase 3 clinical trials of the drug for gastrointestinal indications including GERD and non-erosive reflux disease.

What phase is Omeprazole in?

Omeprazole has been studied in Phase 3 clinical trials. The development program includes completed trials for GERD and non-erosive reflux disease. It is an investigational product in these settings and has not been approved by the FDA for these indications based on the available information.

What clinical trials is Omeprazole in?

Omeprazole has been evaluated in Phase 3 trials including NCT00259077, which studied four-week treatment of non-erosive reflux disease in a Japanese population; NCT00259051, a pharmacodynamic study in the same population; and NCT00256737, which compared omeprazole treatment versus surgery in patients with GERD.