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NCT01592019 · ClinicalTrials.gov registry record · Early Phase 1
Clinical Study to Evaluate the Role of Microdialysis for the Comparison of Topical Products
A Early Phase 1 study, sponsored by University of Florida.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT01592019: Completed Early Phase 1 study, sponsored by University of Florida.
NCT01592019 is a Early Phase 1 study that has completed, run by University of Florida. The registered enrollment target is 6 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01592019, a Early Phase 1 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The investigators hypothesize that a technique called microdialysis can be used to measure the amount of the drug diclofenac which penetrates (enters) the fatty tissue under the skin. Microdialysis uses a small device called a 'probe' to determine the amount of drug which enters a body tissue. The small device is placed directly in the fatty tissue and samples are taken at specific times. The investigators will determine whether site of application affects the availability of the drug.
Primary Outcome
Blood and tissue concentrations (nanograms/milliliter) of the drug diclofenac will be measured and compared between different batches of the product Flector. In addition, the two batches will be compared at different application sites, namely the abdomen and thigh. Tissue concentrations will be measured using microdialysis.
Interventions
- DRUG Reference, Patch location thigh, batch 1
- DEVICE Test, Patch location thigh, batch 2
- DRUG Reference, Patch location abdomen, batch 1
- DEVICE Test, Patch location abdomen, batch 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-04 |
| Est. Completion | 2012-11 |
| Phase | Early Phase 1 |
What the finished NCT01592019 record still lists
NCT01592019 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 4 interventions - of which Reference, Patch location thigh, batch 1 is the first listed.
NCT01592019 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01592019 about?
NCT01592019 is a clinical study titled "Clinical Study to Evaluate the Role of Microdialysis for the Comparison of Topical Products". The investigators hypothesize that a technique called microdialysis can be used to measure the amount of the drug diclofenac which penetrates (enters) the fatty tissue under the skin. Microdialysis uses a small device called a 'probe' to determine the amount of drug which enters a body tissue. The s...
What is the current status of trial NCT01592019?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2012-04. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01592019?
The interventions under investigation include: Reference, Patch location thigh, batch 1 (DRUG), Test, Patch location thigh, batch 2 (DEVICE), Reference, Patch location abdomen, batch 1 (DRUG), Test, Patch location abdomen, batch 2 (DEVICE).
Who is sponsoring clinical trial NCT01592019?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01592019's enrollment target sits among peer trials
6 1846th of 2000 higher than 114 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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