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Lansoprazole microgranules

Phase 3

Gastroesophageal Reflux Disease | Small molecule | Gastrointestinal |Takeda Pharmaceutical Company Limited|Last Updated: Jul 22, 2010

Target and mechanism

ModalitySmall molecule

Also known as Lansoprazole microgranules suspension

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment162

FDA Designations

No designations recorded

Clinical trial landscape

Lansoprazole microgranules · 1 trial · 1 indication

Phase 3 1
NCT00324974The Use of Lansoprazole to Treat Infants With Symptoms of Gastroesophageal RefluxGastroesophageal Reflux Disease
COMPLETED162 Analytics
PHASE3COMPLETED
The Use of Lansoprazole to Treat Infants With Symptoms of Gastroesophageal Reflux
Gastroesophageal Reflux Disease
NCT00324974162
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Study Endpoints

Primary Endpoints

Percentage of subjects in each treatment group responding to treatment with a reduction from baseline in the percentage and duration of crying/fussing/irritability episodes associated with feeding after 4 weeks of treatment.
Week 4
Safety Assessments
Baseline through week 8

Secondary Endpoints

Global Symptom Assessment, as answered by Investigator and Parent/Guardian
Baseline through Week 8
Sensitivity analyses of the primary endpoint
Week 4
Additional Daily Diary-based symptom Assessments
At the end of the double-blind treatment period and 30 days after the last dose of study drug.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lansoprazole QDEXPERIMENTAL -
Placebo QDPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Lansoprazole microgranules suspensionDRUGLansoprazole microgranules 0.2-0.3 mg/kg/day suspension, orally, once daily for up to 28 days for infants less than 10 weeks; Lansoprazole microgranules 1.0-1.5 mg/kg/day suspension, orally, once daily for up to 28 days for infants greater than 10 weeks.
PlaceboDRUGLansoprazole placebo-matching suspension, orally, once daily for up to 28 days.
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Eligibility Criteria

Age Range1 Month to 11 Months
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * At least 7 days post-surgery at the time of Screening (Study Visit 1) with no anticipated need for surgery during the study. * Experiencing symptoms of gastroesophageal reflux disease (regurgitation, vomiting or "spitting up," fussing/irritability, feeding refusal, crying duri...

Countries:United StatesPoland
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