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Magnesium Pantoprazole

Phase 3

GERD | Small molecule | Gastrointestinal |Takeda Pharmaceutical Company Limited|Trials Updated: Jun 26, 2012

Magnesium Pantoprazole development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since May 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment713

FDA Designations

No designations recorded

Magnesium Pantoprazole clinical trials

Magnesium Pantoprazole · 1 trial · 1 indication

Phase 3 1
NCT01132638Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux DiseaseGERD
COMPLETED713 Analytics
PHASE3COMPLETED
Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease
GERDUnlock trial analytics

Study Endpoints

Primary Endpoints

Comparatively evaluation of the clinical efficacy of pantoprazole magnesium and esomeprazole in the treatment of patients with erosive gastroesophageal reflux disease (GERD), considering the proportion of patients in complete remission.
After 4 treatment weeks

A patient is considered at complete remission if he/she achieved symptoms relief and confirmed endoscopic healing at treatment end. A patient achieves symptoms relief if Reflux Questionnaire-GI score ((ReQuest™) stays below 1,73 for at least the three last consecutive treatment days, that can occur at visit V2 or visit V3 for those that did not achieve complete remission at V2 and repeated the treatment for 4 weeks more.

Secondary Endpoints

Treatments comparative evaluation for DRGE ReQuest™-GI and -WSO scores change with respect to baseline measured
After 4 and 8 treatment weeks
Treatments comparative evaluation for the time interval from treatment start to the beginning of symptoms relief
Treatments comparative evaluation for endoscopic healing rate
After 4 and 8 treatment weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Magnesium PantoprazoleACTIVE_COMPARATOR -
Magnesium EsomeprazoleACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Magnesium PantoprazoleDRUG1 capsule daily, 40 mg, orally, 30 minutes before breakfast
Magnesium EsomeprazoleDRUG1 capsule daily, 40 mg, orally, 30 minutes before breakfast
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Voluntary participation in the study with signature on Informed Consent Form (ICF) prior to specific protocol procedures * Patients of any race * On outpatient treatment * History of frequent symptom crises related to GERD within the last 3 months (at least a frequency of twic...

Countries:Brazil
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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 Magnesium Pantoprazole

What is Magnesium Pantoprazole?

Magnesium Pantoprazole is an investigational small molecule developed by Takeda Pharmaceutical Company Limited for gastroesophageal reflux disease, or GERD. It is a magnesium-based formulation of pantoprazole that has been studied in a Phase 3 clinical trial. It is not described as approved and remains in clinical development.

What is Magnesium Pantoprazole used for?

Magnesium Pantoprazole is being developed for the treatment of gastroesophageal reflux disease, commonly known as GERD. Its clinical program has focused on patients with erosive gastroesophageal reflux disease. The drug is investigational and has not been described as approved for any indication.

Who makes Magnesium Pantoprazole?

Magnesium Pantoprazole is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program evaluating the drug in patients with gastroesophageal reflux disease.

What phase is Magnesium Pantoprazole in?

Magnesium Pantoprazole is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently listed as active. The drug is investigational and is not described as approved by the FDA or any other regulatory agency.

What clinical trials is Magnesium Pantoprazole in?

Magnesium Pantoprazole has been evaluated in the Phase 3 trial NCT01132638, titled Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease. The completed trial enrolled 713 patients in Brazil, was randomized, double blind, and active controlled, and included adults 18 years and older.