The purpose of this study is to evaluate the cumulative adhesion percentage for the test products and the reference products for both small and large patches.
This is a randomized (study medication assigned to participants by chance), single-center, parallel-group single-application, modified 3-way crossover study. Each participant will receive the marketed reference formulation (DURAGESIC) or the JNJ-35685-AAA-G016 or JNJ-35685-AAA-G021 fentanyl transdermal system (TDS). The study consists of a screening phase within 21 and 2 days before the first TDS application of the first period; a partially-blinded treatment phase consisting of 3 single-application treatment periods; and end-of-study or withdrawal assessments done upon completion of the 72-hour adhesion assessment on Day 5 of Period 3 or upon withdrawal. A 7- to 16-day washout period will separate the treatment periods, commencing at transdermal patch removal. The duration of participation in the study for an individual participant will be 31 days to a maximum of 68 days (including screening and follow-up visits). Participants will be primarily evaluated for cumulative adhesion percentage. Participants' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Enrollment
52
Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Unnamed facility
Cypress, California, United States
Cumulative Adhesion Percentage
The actual percentages of patch adhesion will be estimated according to the Food and Drug Administration (FDA) 0-4 scoring system. An estimated percentage of adhesion, to a whole integer, will be obtained (FDA 0-4 \[%\] scoring) where 0=greater than or equal to (\>=) 90% adhered (essentially no lift off the skin); 1= \>= 75% to \< 90% adhered (some edges only lifting off the skin); 2 = ≥ 50% to \< 75% adhered (less than half of the patch lifting off the skin); 3 = \> 0% to \< 50% adhered but not detached (more than half of the patch lifting off the skin without falling off); 4 = 0% adhered - patch detached (patch completely off the skin).
Time frame: Time of patch application up to patch removal (up to 72 hours)
Time to First Unacceptable Score
Time to first unacceptable score that is \< 75% adhered will be assessed.
Time frame: 12, 24, 36, 48, 60, and 72 hour following patch application
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.