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esomeprazole magnesium

Phase 3

Zollinger-Ellison Syndrome | Small molecule | Endocrine |AstraZeneca PLC|Last Updated: Nov 19, 2010

Target and mechanism

ModalitySmall molecule

Also known as Esomeprazole magnesium (Nexium)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

esomeprazole magnesium · 2 trials · 3 indications

Phase 3 1Phase 1 1
NCT00079833Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison SyndromeZollinger-Ellison Syndrome
COMPLETED25 Analytics
PHASE3COMPLETED
Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome
Zollinger-Ellison Syndrome
NCT0007983325
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Study Endpoints

Primary Endpoints

To assess the gastric acid secretory rate at the final study visit.
Control is defined as gastric acid secretory rate below 10 mEq/h or below 5 meq/h for patients with prior gastric acid reducing Surgery
Area under the plasma concentration-time curve (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg and 20 mg esomeprazole in pediatric patients 1 to 11 years old inclusive with endoscopically-proven GERD.
Day 1

Secondary Endpoints

The status (controlled or not controlled) of gastric acid secretory rate at the Month 6 study visit.
Control is defined as gastric acid secretory rate below 10 mEq/h or below 5 meq/h for patients with prior gastric acid reducing surgery.
The following safety variables will be assessed at Month 6 and Month 12: adverse events, clinical laboratory results (ie, chemistry, hematology, urinalysis), physical examinations, and EGDs.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALesomeprazole magnesium 5 mg, weight 8 kg to \< 20kg
2EXPERIMENTALesomeprazole magnesium 10 mg, weight 8 kg to \< 20kg
3EXPERIMENTALesomeprazole magnesium 10 mg, weight \> 20 kg
4EXPERIMENTALesomeprazole magnesium 20 mg, weight \> 20 kg

Interventions

NameTypeDescription
Esomeprazole magnesium (Nexium)DRUG -
esomeprazole magnesiumDRUGcapsules, oral, qd, one day
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Males or females at least 18 years of age. * Diagnosis of Zollinger-Ellison Syndrome or idiopathic hypersecretion Exclusion Criteria: * Pregnant or lactating females * History of drug addiction or alcohol abuse within 12 months prior to Screening. * History of intolerance to...

Countries:United StatesFrance
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