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AZD0865

Phase 2

GERD Without Erosive Esophagitis | Small molecule | Gastrointestinal |AstraZeneca PLC|Last Updated: Jan 4, 2013

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment1,400
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00206284A Dose-finding Phase IIb Study With AZD0865 and Esomeprazole in GERD Patients Without Erosive Esophagitis.PHASE2 COMPLETED 1,400May 1, 2004Apr 1, 2005Jan 4, 2013202 United States, Canada +8
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Study Endpoints
Primary Endpoints
Time to sustained absence of patient-reported heartburn.
Secondary Endpoints
The Quality of Life in Reflux and Dyspepsia (QOLRAD).
Patient-reported symptoms.
Investigator-reported symptoms.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
AZD0865DRUG -
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites202

Inclusion Criteria: * Identification of their main symptom as heartburn defined as a burning feeling behind the breastbone. * Have at least a 6-month history of heartburn and at least 4 days of episodes of heartburn with at least overall moderate intensity during the last 7 days prior to visit 1. *...

Countries:United StatesCanadaDenmarkFinlandFranceGermanyItalyNorwaySwedenUnited Kingdom
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