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ADX10059

Phase 2

Gastroesophageal Reflux | Small molecule | Gastrointestinal |Addex Therapeutics Ltd|Last Updated: Jul 16, 2012

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 Trials2
Total Enrollment418
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00810485ADX10059 as an add-on Therapy to Proton Pump Inhibitors (PPIs) in Patients With Gastroesophageal Reflux (GERD)PHASE2 COMPLETED 298Dec 1, 2008 -Jul 16, 201240 United States, France +3
NCT00820079ADX10059 as a Monotherapy in Patients With Gastroesophageal Reflux (GERD)PHASE2 COMPLETED 120Dec 1, 2008 -Dec 24, 200911 Austria, Belgium +2
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Study Endpoints
Primary Endpoints
Number of GERD symptom free days in week 4 of study medication treatment
4 weeks
Number of GERD symptom free days in week 2 of study medication treatment
2 weeks
Secondary Endpoints
GERD symptoms
4 weeks
Sleep disturbance
4 weeks
Use of antacid medications
4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ADX10059 50 mgEXPERIMENTALtwice-daily
ADX10059 100 mgEXPERIMENTALtwice-daily
ADX10059 150 mgEXPERIMENTALtwice-daily
ADX10059 Matching PlaceboPLACEBO_COMPARATORtwice-daily
ADX10059 120 mgEXPERIMENTALTwice-daily
Interventions
NameTypeDescription
ADX10059DRUGoral administration
ADX10059 Matching PlaceboDRUGoral administration
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * diagnosis of typical GERD * partial responder to a stable standard clinical symptoms control dose of PPI therapy * body mass index ≤ 32 kg/m2 Exclusion Criteria: * exclusively atypical symptoms of GERD * symptoms that have been shown not to be associated with GERD * erosive ...

Countries:United StatesFranceGermanyNetherlandsSwitzerlandAustriaBelgium
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