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Pantoprazole

Phase 3

GERD | Small molecule | Gastrointestinal |Takeda Pharmaceutical Company Limited|Last Updated: May 7, 2012

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment628

FDA Designations

No designations recorded

Clinical trial landscape

Pantoprazole · 4 trials · 4 indications

Phase 3 4
NCT00336219Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)GERD
COMPLETED628 Analytics
NCT00312806Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)Gastroesophageal Reflux Disease (GERD)
COMPLETED2,000 Analytics
NCT00163306Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)Gastroesophageal Reflux
COMPLETED1,200 Analytics
NCT00261300Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)Gastroesophageal Reflux Disease (GERD)
COMPLETED100 Analytics
PHASE3COMPLETED
Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)
GERDUnlock trial analytics
PHASE3COMPLETED
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
Gastroesophageal Reflux Disease (GERD)Unlock trial analytics
PHASE3COMPLETED
Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-339)
Gastroesophageal RefluxUnlock trial analytics
PHASE3COMPLETED
Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints (BY1023/VMG-708)
Gastroesophageal Reflux Disease (GERD)Unlock trial analytics

Study Endpoints

Primary Endpoints

symptom assessment as measured by ReQuest™ questionnaire and investigator.
28 days
Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™
8 weeks
complete reflux disease remission rate after 8 weeks of treatment defined as symptom relief assessed by reflux questionnaire (ReQuest Trademark) and endoscopically confirmed healing.
Safety (adverse events, laboratory values).
5 years

Secondary Endpoints

symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator
28 days
endoscopic healing after 28 days
28 days
health-related quality of life after 28 days
28 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORPantoprazole 40 mg

Interventions

NameTypeDescription
PantoprazoleDRUGSymptom Assessment after treatment with Pantoprozole 40 mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites40

Main Inclusion Criteria: * Written informed consent * Outpatients * History of GERD-related symptoms for at least 6 months prior to study inclusion * Endoscopically confirmed erosive GERD or non-erosive GERD Main Exclusion Criteria: * Acute peptic ulcer and/or ulcer complications * PPIs during la...

Countries:AustraliaAustriaGermanyHungaryArgentinaBelgiumBrazilCanadaFranceHong KongIndiaItalyMalaysiaMexicoPolandPortugalSingaporeSouth AfricaSouth KoreaSpainSwitzerlandTaiwanUnited Kingdom
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Competitive Landscape -GERD 4 trials

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