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Nicotine gum

Phase 3

Smoking Cessation | Small molecule | Other |Johnson & Johnson|Last Updated: Apr 25, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment314
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00840242Smoking Reduction or Cessation With Nicotine Replacement TherapyPHASE3 COMPLETED 314Feb 1, 1999May 1, 2000Apr 25, 20122 Czechia
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Study Endpoints
Primary Endpoints
Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels
Baseline to 6 weeks, 3 and 4 months
Secondary Endpoints
Changes in laboratory values of cardiovascular risk factors
Baseline up to 12 months
Changes in clinical and laboratory exposure parameters
Baseline up to 12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Nicotine gumEXPERIMENTALNicotine gum
Placebo gumPLACEBO_COMPARATORPlacebo gum
Nicotine inhalerACTIVE_COMPARATORNicotine inhaler
Placebo inhalerPLACEBO_COMPARATORPlacebo inhaler
Interventions
NameTypeDescription
Nicotine gumDRUG8-12 pieces per day, maximum 24 daily
Placebo gumDRUG8-12 pieces per day, maximum 24 daily
Nicotine inhalerDRUG6-12 cartridges per day, maximum 12 daily
Placebo inhalerDRUG6-12 cartridges per day, maximum 12 daily
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Age above 18 * Smoking \>/= 15 cigarettes/day * Having smoked for 3 years or more * CO \>/= 10ppm at inclusion * Want to reduce smoking * Prepared to adhere to the protocol * Willing to provide signed informed consent * Having made at least one serious attempt to quit smoking ...

Countries:Czechia
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