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NCT01380353 · ClinicalTrials.gov registry record · Early Phase 1

Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine

A Early Phase 1 study, sponsored by Northwestern University.

Completed
Registry status
Early Phase 1
Development phase
30
Enrollment target

NCT01380353: Completed Early Phase 1 study, sponsored by Northwestern University.

NCT01380353 is a Early Phase 1 study that has completed, run by Northwestern University. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01380353, a Early Phase 1 study, has completed, sponsored by Northwestern University.

COMPLETED
Registry status
Early Phase 1
Development phase
30 participants
Enrollment target

Study Summary

The purpose of this study is to look for ways to improve breast cancer treatment by giving breast cancer drugs through the skin of the breast. The drug used in this study is a diclofenac epolamine patch and is a nonsteroid anti-inflammatory pain reliever. The drug amount that gathers in the breast, after application of a patch to the skin of the breast, will be measured and compared to the amount that is found in the breast when the patch is applied to the skin of the belly.

Primary Outcome

The primary objective of this protocol will demonstrate that diclofenac epolamine patch applied to the skin of the breast for three days (1, 2) prior to surgery will result in significantly higher drug concentrations in the breast than the same dose applied to the abdominal skin for the same duration of time.

Interventions

  • DRUG Diclofenac epolamine patch

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2011-06
Est. Completion 2012-11-12
Phase Early Phase 1
Northwestern University

1,209 total trials

What the finished NCT01380353 record still lists

NCT01380353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).

The record links to 0 conditions, and to 1 intervention - of which Diclofenac epolamine patch is the first listed.

NCT01380353 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01380353 about?

NCT01380353 is a clinical study titled "Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine". The purpose of this study is to look for ways to improve breast cancer treatment by giving breast cancer drugs through the skin of the breast. The drug used in this study is a diclofenac epolamine patch and is a nonsteroid anti-inflammatory pain reliever. The drug amount that gathers in the breast,...

What is the current status of trial NCT01380353?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2011-06. Estimated completion is 2012-11-12.

What interventions are being tested in trial NCT01380353?

The interventions under investigation include: Diclofenac epolamine patch (DRUG).

Who is sponsoring clinical trial NCT01380353?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01380353's enrollment target sits among peer trials

30 807th of 2000 higher than 1,074 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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Source: ClinicalTrials.gov NCT01380353, the US trial registry maintained by the National Library of Medicine. NCT01380353 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.