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Nicotine Patch

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
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials5
Total Enrollment584
FDA Designations
No designations recorded
Clinical Trials (5)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01075659Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ LozengePHASE2 COMPLETED 200 — — Feb 1, 2010May 1, 2010Jul 10, 20121 Sweden
NCT00966901Photoirritation and Photoallergic Potential of a New Nicotine PatchPHASE1 COMPLETED 43 — — Aug 1, 2005Oct 1, 2005Jul 10, 20121 Germany
NCT00965913Cumulative Skin Irritation Potential of a New 15 mg Nicotine PatchPHASE1 COMPLETED 42 — — May 1, 2005Jun 1, 2005Jun 29, 20121 Germany
NCT00967070Skin Sensitization Potential of a New Nicotine PatchPHASE1 COMPLETED 257 — — May 1, 2005Aug 1, 2005Jul 10, 20121 Germany
NCT00967174Cumulative Skin Irritation Potential of a New 25 mg Nicotine PatchPHASE1 COMPLETED 42 — — May 1, 2005Jun 1, 2005Jul 10, 20121 Germany
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Study Endpoints
Primary Endpoints
Areas under the linearly interpolated urges to smoke vs. time curve evaluated in a hierarchical order starting with the 5 minutes' evaluation (AUC5min, AUC3min, AUC1min)
from time zero following 5 hours of smoking abstinence (baseline), until 5 minutes, until 3 minutes, and until 1 minute, respectively
Cumulative Individual Irritation Scores after UVA and UVB exposure
15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase.
Cumulative Irritation Score (CIS10)
@24 hours post- application for 21 days
Cumulative Individual Irritation Scores
15 or 30 min, and 24, 48, and 72 hr post-application, depending on trial phase
Secondary Endpoints
Areas under the linearly interpolated urges to smoke vs. time curve (AUC10min)
from time zero following 5 hours of smoking abstinence (baseline), until 10 minutes thereafter
Time to a 25%, 50%, 75%, and 90% reduction from baseline intensity of urges to smoke score
from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter
Proportion of subjects reaching 25%, 50%, 75% and 90% reduction of urges to smoke
from time zero following 5 hours of smoking abstinence (baseline), until 2 hours thereafter
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LHN1548EXPERIMENTALTwo single doses of an experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.
2019706ACTIVE_COMPARATORTwo single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.
2020005ACTIVE_COMPARATORTwo single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.
Three Treatment Sites UV ExposedEXPERIMENTALAll three test sites exposed to UV radiation after patch removal. Induction: 10 J/cm2 UVA and 0.5 MED UVB, one treatment after first patch removal; and 3 MED UVB at the 5 following treatments. Challenge: 4 J/cm2 UVA and 0.5MED UVB, one treatment.( MED: Minimal Erythema Dose determined during screening)
Three Interventions on Lower BackEXPERIMENTALThree treatments were applied on the lower back, according to treatment sequence, daily for 21 days
Both Treatments Applied on Lower BackEXPERIMENTALTreatments were applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h.
Three Treatments Applied to Lower BackEXPERIMENTALTreatments were applied on the lower back, according to treatment sequence, daily for 21 days.
Interventions
NameTypeDescription
NicotineDRUGTwo single doses of experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period
Nicotine PatchDRUG25 mg nicotine patch applied on the assigned marked site on the lower back or buttock. Induction (23 days): six treatment applications for 24 h. Challenge (five days): one treatment application for 24 h.
Placebo PatchDRUGAs a positive control, a placebo patch applied on the assigned marked site on the lower back or buttock. Induction (23 days): six treatment applications for 24 h. Challenge (five days): one treatment application for 24 h.
No Patch ControlDRUGAs a negative control, a marked site on the lower back or buttock was assigned as test area, but no patch was applied.
UVA and UVB irradiationRADIATIONAll three test sites exposed to UV radiation after patch removal. Induction: 10 J/cm2 UVA and 0.5 MED UVB, one treatment after first patch removal; and 3 MED UVB at the 5 following treatments. Challenge: 4 J/cm2 UVA and 0.5MED UVB, one treatment.( MED: Minimal Erythema Dose determined during screening)
Nicotine Patch ComparatorDRUG15 mg nicotine patch applied on the lower back, according to treatment sequence, daily for 21 days
SLS Comparator PatchDRUG0.1% (w/v) SLS patch applied on the lower back, according to treatment sequence, daily for 21 days.
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Eligibility Criteria
Age Range19 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Healthy smokers, smoking at least 10 cigarettes daily during at least one year preceding inclusion, and smoking within 30 minutes of waking up. * Female participants of child-bearing potential are required to use a medically acceptable means of birth control. * A personally si...

Countries:SwedenGermany
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