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NCT02608320 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With Duragesic Fentanyl Transdermal Patch in Healthy Participants
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT02608320: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT02608320 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02608320, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Interventions
- DRUG Duragesic (Fentanyl Transdermal System [TDS] Small Patches)
- DRUG New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)
- DRUG Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)
- DRUG Duragesic (Fentanyl TDS Large Patches)
- DRUG New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2015-11-17 |
| Est. Completion | 2016-04-13 |
| Phase | Phase 1 |
What the finished NCT02608320 record still lists
NCT02608320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 5 interventions - of which Duragesic (Fentanyl Transdermal System [TDS] Small Patches) is the first listed.
NCT02608320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02608320 about?
NCT02608320 is a clinical study titled "A Study to Evaluate the Adherence of 2 Strengths of Newly Manufactured Samples and Aged Samples of a New Formulation (JNJ-35685-AAA-G016 and JNJ-35685-AAA-G021) of Fentanyl Transdermal System Compared With Duragesic Fentanyl Transdermal Patch in Healthy Participants". 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.
What is the current status of trial NCT02608320?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2015-11-17. Estimated completion is 2016-04-13.
What interventions are being tested in trial NCT02608320?
The interventions under investigation include: Duragesic (Fentanyl Transdermal System [TDS] Small Patches) (DRUG), New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches) (DRUG), Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches) (DRUG), Duragesic (Fentanyl TDS Large Patches) (DRUG), New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches) (DRUG).
Who is sponsoring clinical trial NCT02608320?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02608320's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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