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Nicotine replacement therapy

Phase 2

Smoking Cessation | Small molecule | Other |Johnson & Johnson|Last Updated: Jul 10, 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment258
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00764439Pilot Study of a New Nicotine Replacement TherapyPHASE2 COMPLETED 258Oct 1, 2008Dec 1, 2008Jul 10, 20122 United Kingdom
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Study Endpoints
Primary Endpoints
Mean hourly and daily number of doses used
throughout study
Secondary Endpoints
Mean number of NRT use occasions per day
Week 1, 2, and 3
Ratings of craving/urge to smoke and withdrawal symptoms
Day 1-14, and Day 20
Self-reported continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm
Day 1-21
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORStandard NRT user direction
2EXPERIMENTALNovel NRT user direction
Interventions
NameTypeDescription
Nicotine replacement therapyDRUGNicotine replacement therapy with Standard NRT user direction
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * 18 years or older male and female cigarette smokers motivated and willing to stop smoking * female participants of child-bearing potential should use a medically acceptable means of birth control * evidence of a personally signed and dated informed consent document indicating ...

Countries:United Kingdom
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