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Octreotide LAR

Phase 3

Acromegaly | Small molecule | Endocrine |Novartis AG|Last Updated: Apr 30, 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
RandomizedUNCONTROLLED
Total Trials2
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00128232Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic PatientsPHASE3 COMPLETED 100 — — Dec 1, 2002 -Apr 30, 2012 - —
NCT00225979Safety and Efficacy of Long-acting Repeatable Octreotide Acetate for Injectable Suspension vs. Surgery in Treatment-naïve Patients With AcromegalyPHASE3 COMPLETED 100 — — Nov 1, 2002Mar 1, 2005Apr 11, 2012 - —
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Study Endpoints
Primary Endpoints
Mean GH and IGF-I at baseline, week 12, 24 and 48
Secondary Endpoints
Tumor volume at baseline, week 24 and 48
Signs and symptoms of acromegaly at baseline, week 12, 24 and 48
Safety and tolerability at any time on treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SMS995EXPERIMENTAL -
Interventions
NameTypeDescription
Octreotide LARDRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Newly diagnosed or previously untreated acromegalic patients * Lack of suppression of growth hormone (GH) nadir to \<1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test \[OGTT\]) * Insulin-like growth factor-I (IGF-I) levels above the upper limit...

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