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Magnesium Pantoprazole

Phase 3

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

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

Clinical trial landscape

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
GERD
NCT01132638713
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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 4 trials

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