MedTrace Logo

Irritation and Sensitization Potential of Repeat Applications of Rotigotine Patch

NCT02727205 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2016-04-04

No results posted yet for this 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

Conditions

  • Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch

Interventions

DRUG

Rotigotine Transdermal System

Sponsors & Collaborators

  • Inflamax Research Incorporated

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02727205 on ClinicalTrials.gov