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Open Label Run In Esomeprazole

Phase 3

Gastroesophageal Reflux Disease (GERD) | Small molecule | Gastrointestinal |AstraZeneca PLC|Last Updated: Jun 2, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment98
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00468559Phase 3/Safety & Efficacy of Esomeprazole in InfantsPHASE3 COMPLETED 98 — — Apr 1, 2007Jun 1, 2008Jun 2, 201425 United States, France +2
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Study Endpoints
Primary Endpoints
Number of Participants Discontinuing Due to Symptom Worsening in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)
Treatment-withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)

Number of participants discontinuing during the 4-week of randomized double-blind withdrawal phase that met the pre-set definition of symptom worsening criteria.

Secondary Endpoints
Number of Participants Discontinuing Due to Any Reason, Including Symptom Worsening, in the Randomized Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint)
Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
Treatment Successes at the End of the 4-week Double-blind Treatment Withdrawal Phase (Treatment Withdrawal Phase Endpoint).
Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
Physician's Global Assessment (PGA) of Gastroesophageal Reflux Disease (GERD) Symptoms (Treatment Withdrawal Phase Endpoint)
Treatment withdrawal phase (up to 4 weeks following randomization, or until earlier discontinuation from the study)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Open Label EsomeprazoleEXPERIMENTALThis is an open label, run-in phase. All patients received Esomeprazole.
Double Blind EsomeprazoleEXPERIMENTALThis is the double blind withdrawal phase. Patients are randomized to active drug or placebo.
Double Blind PlaceboPLACEBO_COMPARATORThis is the double blind withdrawal phase. Patients are randomized to active drug or placebo.
Interventions
NameTypeDescription
Open Label Run In EsomeprazoleDRUGEsomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
Double Blind EsomeprazoleDRUGEsomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)
Double Blind PlaceboDRUGDouble Blind Placebo
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Eligibility Criteria
Age Range1 Month — 11 Months
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * patients' parents must sign the informed consent prior to the beginning of any study-related procedures (according to local regulations) * patients must have symptoms at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or GERD proven by a test cal...

Countries:United StatesFranceGermanyPoland
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