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NCT02727205 · ClinicalTrials.gov registry record · Phase 1

Irritation and Sensitization Potential of Repeat Applications of Rotigotine Patch

A Phase 1 study of Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch, sponsored by Inflamax Research Incorporated.

Completed
Registry status
Phase 1
Development phase
260
Enrollment target
2
Study locations

NCT02727205 is a Phase 1 study of Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch that has completed, run by Inflamax Research Incorporated. The registered enrollment target is 260 participants. The trial reports 2 study locations across 2 states.

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The verdict

NCT02727205, a Phase 1 study of Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch, has completed, sponsored by Inflamax Research Incorporated.

COMPLETED
Registry status
Phase 1
Development phase
260 participants
Enrollment target
2
Study locations

Study Summary

STUDY TITLE: A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine Transdermal System), 1 mg/24 hr in Healthy Volunteers TEST DRUG / INVESTIGATIONAL PRODUCT: Rotigotine Transdermal System, 1 mg/24 hr INDICATION STUDIED: Bioequivalence - Irritation and Sensitization STUDY DESIGN: * Multiple-site, randomized, multiple-application, evaluator-blinded, controlled study * One-half (½) of the test patch and one-half (½) of the reference patch was applied daily to the same site for each product over a 21 day period followed by a rest phase and a challenge phase

Interventions

  • DRUG Rotigotine Transdermal System

Study Locations (2)

Florida

  • Clinical Pharmacology of Miami, Inc. - Miami

Ontario

  • Inflamax Research Inc. - Mississauga

Trial Details

FieldValue
Enrollment Target 260 participants
Start Date 2013-08
Est. Completion 2013-10
Phase Phase 1

Sponsor

Inflamax Research Incorporated

1 total trials

What the Registry Record Tells You About NCT02727205

The ClinicalTrials.gov registry entry for NCT02727205 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inflamax Research Incorporated, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch appearing as the primary indexed condition, and to 1 intervention - of which Rotigotine Transdermal System is the first listed.

NCT02727205 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Ontario.

Frequently Asked Questions

What is clinical trial NCT02727205 about?

NCT02727205 is a clinical study titled "Irritation and Sensitization Potential of Repeat Applications of Rotigotine Patch". STUDY TITLE: A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine Transdermal System), 1 mg/24 hr in Healthy Volunteers TEST DRUG / INVESTIGATIONAL PRODUCT: Rotigotine Transdermal...

What is the current status of trial NCT02727205?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 260 participants. The study started on 2013-08. Estimated completion is 2013-10.

What conditions does trial NCT02727205 study?

This clinical trial studies the following conditions: Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch.

What interventions are being tested in trial NCT02727205?

The interventions under investigation include: Rotigotine Transdermal System (DRUG).

Who is sponsoring clinical trial NCT02727205?

This trial is sponsored by Inflamax Research Incorporated, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02727205 being conducted?

This trial has 2 study locations across Florida, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.