Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02221726 | Study to Assess Adhesion Quality and Wear of Placebo JNJ-35685-AAA-G-023 Transdermal System in Healthy Adults | EARLY_PHASE1 | COMPLETED | 16 | — | — | Aug 1, 2014 | Aug 1, 2014 | Sep 15, 2014 | 1 | United States |
Visual grading US FDA scale will be used to evaluate adhesion performance of the transdermal system. The score ranges from 0-4: 0 = greater than or equal to (\>=) 90 percent (%) adhered (essentially no lift off the skin); 1 = greater than or equal to 75% to less than (\<) 90% adhered (some edges only lifting off the skin); 2 = greater than or equal to 50% to \<75% adhered (less than half of the patch lifting off the skin); 3 = greater than (\>) 0% to \<50% adhered but not detached (more than half of the patch lifting off the skin without falling off); and 4 = 0% adhered - patch detached (patch completely off the skin).
Digital image will be captured with high resolution for each transdermal patch site and adhesion area will be calculated.
Total adhesion score will be calculated by visual grading grid system (a grid system based on 20 four-sided divisions that are approximately 5% of the total patch area; 44 cm\^2 patch will be evaluated by square and rectangular grid elements while 5.5 cm\^2 patch will be evaluated by square grid element only) which also contains a scale to allow for proper determination of actual area of the patch not adhering to the skin. Total area of the patch which does not adhere will be calculated. Any area of the patch that does not entirely adhere onto the skin will be scored as 0% adhesion for that area. Subsequently, a total adhesion score for that system will be calculated.
| Arm | Type | Description |
|---|---|---|
| JNJ-35684-AAA-023: 5.5 cm^2 Patch | EXPERIMENTAL | - |
| JNJ-35684-AAA-023: 44 cm^2 Patch | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| JNJ-35684-AAA-023: Size 1; small patch | DRUG | 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. |
| JNJ-35684-AAA-023: Size 2; large patch | DRUG | 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. |
Inclusion Criteria: * Body mass index (BMI: weight in kilogram \[kg\]/height\^2 \[meter (m\^2)\]) between 18 and 35 kg/m\^2 (inclusive), and body weight not less than 50 kg * Blood pressure (can be taken in supine or sitting position) between 90 and 140 milimeter of mercury (mmHg) systolic, inclusi...