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BRL29060A

Phase 3

Social Phobia | Small molecule | Other |GSK plc|Last Updated: Apr 15, 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
UNCONTROLLED
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00264654Long-term Study Of Paroxetine in Women and MenPHASE3 COMPLETED 50 — — Oct 1, 2005Nov 1, 2005Apr 15, 20133 Japan,
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Study Endpoints
Primary Endpoints
Change from baseline in the LSAS total score at week 52 (Score at week 52- Score at week 0)
52 Weeks
Secondary Endpoints
Proportion of patients responding with a CGI Global Improvement Item. Change from baseline in the CGI Severity of Illness score. Change from baseline in the HAM-D total score. Proportion of patients continuing treatment.
52 Weeks
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
BRL29060ADRUG -
paroxetine hydrochloride hydrateDRUG -
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Eligibility Criteria
Age Range18 Years — 64 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria: * Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder) according to DSM-IV-TR criteria. * Must give a written informed consent. * If the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written infor...

Countries:Japan
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