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| ID | Type | Description | Link |
|---|---|---|---|
| FENPAI1025 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Treatment Sequence (BCA) Position (RLR) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 of patch application up to patch removal (up to 72 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Unacceptable Score | Time to first unacceptable score that is < 75% adhered will be assessed. | 12, 24, 36, 48, 60, and 72 hour following patch application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cypress | California | United States |
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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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| C076628 | tyramine-deoxysorbitol |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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