Study to Assess Adhesion Quality and Wear of Placebo JNJ-35685-AAA-G-023 Transdermal System in Healthy Adults
NCT02221726 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2014-09-15
Summary
The purpose of this study is to assess 3 different scoring systems to evaluate the adhesive quality of placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial\]) JNJ-35685-AAA-G-023-G transdermal (through the skin) systems during a single system 72-hour application, replicated 3 times, of 2 patch sizes (5.5 centimeter\^2 \[cm\^2\] and 44 cm\^2).
Conditions
- Healthy
Interventions
- DRUG
-
JNJ-35684-AAA-023: Size 1; small patch
Placebo (matched to Fentanyl transdermal delivery device system \[TDDS\]) JNJ-35685-AAA-G-023 TDDS, 5.5 centimeter square (cm\^2) will be applied vertically to 1 side of the paraspinal region, replicated 3 times, and worn for 72 hours.
- DRUG
-
JNJ-35684-AAA-023: Size 2; large patch
Placebo (matched to Fentanyl transdermal delivery device system \[TDDS\]) JNJ-35685-AAA-G-023 TDDS, 44 cm\^2 (Size 1; small patch) will be applied vertically to other side of the paraspinal region, replicated 3 times, and worn for 72 hours.
Sponsors & Collaborators
-
Janssen Research & Development, LLC
lead INDUSTRY
Principal Investigators
-
Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-08-31
- Primary Completion
- 2014-08-31
- Completion
- 2014-08-31
Countries
- United States
Study Locations
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