Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Duragesic (Fentanyl Transdermal System [TDS] Small Patches)
Duragesic · 1 trial · 1 indication
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).
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence (ACB) Position (RLR) | EXPERIMENTAL | Participants will receive treatment A (Duragesic 12.5 microgram per hour \[mcg/h\]) applied to right paraspinal side in period 1, then treatment C (aged JNJ- 35685-AAA-G016 12.5 mcg/h) applied to left paraspinal side in period 2 and then treatment B (New JNJ-35685- AAA-G016 12.5 mcg/h) applied to right paraspinal side in period 3. |
| Treatment Sequence (BAC) Position (RLR) | EXPERIMENTAL | Participants will receive treatment B applied to right paraspinal side in period 1, then treatment A applied to left paraspinal side in period 2 and then treatment C applied to right paraspinal side in period 3. |
| Treatment Sequence (CBA) Position (RLR) | EXPERIMENTAL | Participants will receive treatment C applied to right paraspinal side in period 1, then treatment B applied to left paraspinal side in period 2 and then treatment A applied to right paraspinal side in period 3. |
| Treatment Sequence (BCA) Position (RLR) | EXPERIMENTAL | Participants will receive treatment B applied to right paraspinal side in period 1, then treatment C applied to left paraspinal side in period 2 and then treatment A applied to right paraspinal side in period 3. |
| Treatment Sequence (CAB) Position (RLR) | EXPERIMENTAL | Participants will receive treatment C applied to right paraspinal side in period 1, then treatment A applied to left paraspinal side in period 2 and then treatment B applied to right paraspinal side in period 3. |
| Treatment Sequence (ABC) Position (RLR) | EXPERIMENTAL | Participants will receive treatment A applied to right paraspinal side in period 1, then treatment B applied to left paraspinal side in period 2 and then treatment C applied to right paraspinal side in period 3. |
| Treatment Sequence (ACB) Position (LRL) | EXPERIMENTAL | Participants will receive treatment A applied to left paraspinal side in period 1, then treatment C applied to right paraspinal side in period 2 and then treatment B applied to left paraspinal side in period 3. |
| Treatment Sequence (BAC) Position (LRL) | EXPERIMENTAL | Participants will receive treatment B applied to left paraspinal side in period 1, then treatment A applied to right paraspinal side in period 2 and then treatment C applied to left paraspinal side in period 3. |
| Treatment Sequence (CBA) Position (LRL) | EXPERIMENTAL | Participants will receive treatment C applied to left paraspinal side in period 1, then treatment B applied to right paraspinal side in period 2 and then treatment A applied to left paraspinal side in period 3. |
| Treatment Sequence (BCA) Position (LRL) | EXPERIMENTAL | Participants will receive treatment B applied to left paraspinal side in period 1, then treatment C applied to right paraspinal side in period 2 and then treatment A applied to left paraspinal side in period 3. |
| Treatment Sequence (CAB) Position (LRL) | EXPERIMENTAL | Participants will receive treatment C applied to left paraspinal side in period 1, then treatment A applied to right paraspinal side in period 2 and then treatment B applied to left paraspinal side in period 3. |
| Treatment Sequence (ABC) Position (LRL) | EXPERIMENTAL | Participants will receive treatment A applied to left paraspinal side in period 1, then treatment B applied to right paraspinal side in period 2 and then treatment C applied to left paraspinal side in period 3. |
| Treatment Sequence (DFE) Position (RLR) | EXPERIMENTAL | Participants will receive treatment D (Duragesic 100 mcg/h) applied to right paraspinal side in period 1, then treatment F (aged JNJ-35685-AAA-G021 100 mcg/h) applied to left paraspinal side in period 2 and then treatment E (new JNJ-35685-AAA-G021 100 mcg/h) applied to right paraspinal side in period 3. |
| Treatment Sequence (EDF) Position (RLR) | EXPERIMENTAL | Participants will receive treatment E applied to right paraspinal side in period 1, then treatment D applied to left paraspinal side in period 2 and then treatment F applied to right paraspinal side in period 3. |
| Treatment Sequence (FED) Position (RLR) | EXPERIMENTAL | Participants will receive treatment F applied to right paraspinal side in period 1, then treatment E applied to left paraspinal side in period 2 and then treatment D applied to right paraspinal side in period 3. |
| Treatment Sequence (EFD) Position (RLR) | EXPERIMENTAL | Participants will receive treatment E applied to right paraspinal side in period 1, then treatment F applied to left paraspinal side in period 2 and then treatment D applied to right paraspinal side in period 3. |
| Treatment Sequence (FDE) Position (RLR) | EXPERIMENTAL | Participants will receive treatment F applied to right paraspinal side in period 1, then treatment D applied to left paraspinal side in period 2 and then treatment E applied to right paraspinal side in period 3. |
| Treatment Sequence (DEF) Position (RLR) | EXPERIMENTAL | Participants will receive treatment D applied to right paraspinal side in period 1, then treatment E applied to left paraspinal side in period 2 and then treatment F applied to right paraspinal side in period 3. |
| Treatment Sequence (DFE) Position (LRL) | EXPERIMENTAL | Participants will receive treatment D applied to left paraspinal side in period 1, then treatment F applied to right paraspinal side in period 2 and then treatment E applied to left paraspinal side in period 3. |
| Treatment Sequence (EDF) Position (LRL) | EXPERIMENTAL | Participants will receive treatment E applied to left paraspinal side in period 1, then treatment D applied to right paraspinal side in period 2 and then treatment F applied to left paraspinal side in period 3. |
| Treatment Sequence (FED) Position (LRL) | EXPERIMENTAL | Participants will receive treatment F applied to left paraspinal side in period 1, then treatment E applied to right paraspinal side in period 2 and then treatment D applied to left paraspinal side in period 3. |
| Treatment Sequence (EFD) Position (LRL) | EXPERIMENTAL | Participants will receive treatment E applied to left paraspinal side in period 1, then treatment F applied to right paraspinal side in period 2 and then treatment D applied to left paraspinal side in period 3. |
| Treatment Sequence (FDE) Position (LRL) | EXPERIMENTAL | Participants will receive treatment F applied to left paraspinal side in period 1, then treatment D applied to right paraspinal side in period 2 and then treatment E applied to left paraspinal side in period 3. |
| Treatment Sequence (DEF) Position (LRL) | EXPERIMENTAL | Participants will receive treatment D applied to left paraspinal side in period 1, then treatment E applied to right paraspinal side in period 2 and then treatment F applied to left paraspinal side in period 3. |
| Name | Type | Description |
|---|---|---|
| Duragesic (Fentanyl Transdermal System [TDS] Small Patches) | DRUG | 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 (Fentanyl TDS -Small Patches) | DRUG | 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 (Fentanyl TDS Small Patches) | DRUG | 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. |
| Duragesic (Fentanyl TDS Large Patches) | DRUG | 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 (Fentanyl TDS Large Patches) | DRUG | 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 (Fentanyl TDS Large Patches) | DRUG | 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. |
Inclusion Criteria: * Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This determination must be recorded in the participant's source documents and initialed by the investigator * A woman of ...