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AH23844

Phase 2

Gastroesophageal Reflux Disease | Small molecule | Gastrointestinal |GSK plc|Last Updated: Jan 19, 2017

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 Enrollment92
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00405119A Study To Investigate The Effectiveness Of AH234844 (Lavoltidine) Compared With NEXIUM And Ranitidine.PHASE2 COMPLETED 92May 1, 2006Mar 1, 2007Jan 19, 20172 Australia
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Study Endpoints
Primary Endpoints
pH over 24hours
over 24hours
Secondary Endpoints
%24 hours pH>4 Median gastric pH Adverse events
over 24 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeDIAGNOSTIC
Interventions
NameTypeDescription
AH23844 (lavoltidine)DRUG -
NEXIUM (esomeprazole)DRUG -
ZANTAC (ranitidine)DRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion criteria: * Subject must have a Body Mass Index (BMI) from 19-30 kg/m2 * Subject does not present with abnormal clinical lab findings * Subject is able to tolerate a nasogastric pH electrode. Exclusion criteria: * Subject is Helicobacter-positive on a C13 urea breath test * Subject has ...

Countries:Australia
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