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lesogaberan

Phase 2

Gastroesophageal Reflux Disease | Small molecule | Gastrointestinal |AstraZeneca PLC|Last Updated: Apr 25, 2011

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 Enrollment661
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01005251Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPIPHASE2 COMPLETED 661 — — Oct 1, 2009Jul 1, 2010Apr 25, 20111 United States
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Study Endpoints
Primary Endpoints
Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation)
The 7 days before randomisation (baseline) and during 26-30 days of treatment

Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary. (GERD = Gastroesophageal Reflux Disease)

Secondary Endpoints
Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.
The 7 days before randomisation (baseline) and during 26-30 days of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
60 mgEXPERIMENTALPPI+lesogaberan (AZD3355) 60 mg bid
120 mgEXPERIMENTALPPI+lesogaberan (AZD3355) 120 mg bid
180 mgEXPERIMENTALPPI+lesogaberan (AZD3355) 180 mg bid
240 mgEXPERIMENTALPPI+lesogaberan (AZD3355) 240 mg bid
PlaceboPLACEBO_COMPARATORPPI+ Placebo
Interventions
NameTypeDescription
lesogaberan (AZD3355)DRUG60 mg, oral, capsules, bid for 4 w
PlaceboDRUGoral,capsules, bid for 4 w
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * Have at least 6 months history of GERD * Continuously treated during the last 4 weeks before enrolment with daily optimized unchanged PPI therapy for any GERD indication Exclusion Criteria: * Patients tha...

Countries:United States
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