Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations

August 26, 2011 updated by: UCB Pharma

A Multicenter, Randomized, Double-blind, Two-way Cross-over Study to Compare the Adhesiveness of Two Different Rotigotine Patch Formulations in Subjects With Parkinson's Disease

The primary objective of the study is to compare the adhesiveness of two different patch formulations of rotigotine using patch size 40 cm2, under the assumption that both patch formulations show similar adhesiveness properties.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria
      • Wien, Austria
  • Germany
      • Alzenau, Germany
      • Berlin, Germany
      • Boblingen, Germany
      • Bochum, Germany
      • Gera, Germany
      • Karlstadt, Germany
      • Koln, Germany
      • Stuttgart, Germany
      • Wolfach, Germany
  • United Kingdom
      • Blackpool, United Kingdom
      • Derby, United Kingdom
      • Liverpool, United Kingdom
      • Newcastle Upon Tyne, United Kingdom
      • Norwich, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with a diagnosis of idiopathic Parkinson´s disease, and continuous treatment with commercially available rotigotine transdermal patch for at least 3 months, and a stable rotigotine dose including an 8 mg/24 h patch for at least 2 weeks prior to enrollment

Exclusion Criteria:

  • Subjects has previously participated in this study, failed to be screened, or has participated in another study with an investigational medicinal product (IMP) or medical device within the last 30 days or is currently participating in such
  • Subject with a history of significant skin hypersensitivity to adhesives, other transdermal products or recently unsolved contact dermatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A-B
4 day treatment (Treatment A: Rotigotine transdermal patch 8 mg/24 h, test product PR 2.2.1 followed by Treatment B: Rotigotine transdermal patch 8 mg/24 h reference patch PR 2.1.1)
Drug: Rotigotine transdermal patch
8 mg/24 h, transdermal patch 8 mg/24 h, 2 days
Other Names:
  • Neupro
Experimental: Sequence B-A
4 day treatment (Treatment B: Rotigotine transdermal patch 8 mg/24 h reference patch PR 2.1.1 followed by Treatment A: Rotigotine transdermal patch 8 mg/24 h, test product PR 2.2.1)
Drug: Rotigotine transdermal patch
8 mg/24 h, transdermal patch 8 mg/24 h, 2 days
Other Names:
  • Neupro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The average adhesiveness score of 2 days of 24 hours patch application as rated by the investigator (or designee)
Time Frame: 2 days of 24 hours patch application
The international patch adhesiveness score
2 days of 24 hours patch application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patch adhesiveness of first treatment day as rated by the investigator (or designee) 24 hours after patch application
Time Frame: after 24 hours of patch application
The international patch adhesiveness score
after 24 hours of patch application
Patch adhesiveness of second treatment day as rated by the investigator (or designee) 24 hours after patch application
Time Frame: after 24 hour of patch application
The international patch adhesiveness score
after 24 hour of patch application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

April 18, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 20, 2011

Study Record Updates

Last Update Posted (Estimate)

August 30, 2011

Last Update Submitted That Met QC Criteria

August 26, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP1066
  • 2010-024250-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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