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Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Rotigotine transdermal patch
Sponsored by
UCB Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Rotigotine, Neupro

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sequence A-B

Sequence B-A

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

The average adhesiveness score of 2 days of 24 hours patch application as rated by the investigator (or designee)
The international patch adhesiveness score

Secondary Outcome Measures

Patch adhesiveness of first treatment day as rated by the investigator (or designee) 24 hours after patch application
The international patch adhesiveness score
Patch adhesiveness of second treatment day as rated by the investigator (or designee) 24 hours after patch application
The international patch adhesiveness score

Full Information

First Posted
April 18, 2011
Last Updated
August 26, 2011
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT01338896
Brief Title
Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Rotigotine, Neupro

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence A-B
Arm Type
Experimental
Arm Description
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)
Arm Title
Sequence B-A
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Rotigotine transdermal patch
Other Intervention Name(s)
Neupro
Intervention Description
8 mg/24 h, transdermal patch 8 mg/24 h, 2 days
Primary Outcome Measure Information:
Title
The average adhesiveness score of 2 days of 24 hours patch application as rated by the investigator (or designee)
Description
The international patch adhesiveness score
Time Frame
2 days of 24 hours patch application
Secondary Outcome Measure Information:
Title
Patch adhesiveness of first treatment day as rated by the investigator (or designee) 24 hours after patch application
Description
The international patch adhesiveness score
Time Frame
after 24 hours of patch application
Title
Patch adhesiveness of second treatment day as rated by the investigator (or designee) 24 hours after patch application
Description
The international patch adhesiveness score
Time Frame
after 24 hour of patch application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Innsbruck
Country
Austria
City
Wien
Country
Austria
City
Alzenau
Country
Germany
City
Berlin
Country
Germany
City
Boblingen
Country
Germany
City
Bochum
Country
Germany
City
Gera
Country
Germany
City
Karlstadt
Country
Germany
City
Koln
Country
Germany
City
Stuttgart
Country
Germany
City
Wolfach
Country
Germany
City
Blackpool
Country
United Kingdom
City
Derby
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
Newcastle Upon Tyne
Country
United Kingdom
City
Norwich
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24006953
Citation
Elshoff JP, Timmermann L, Schmid M, Arth C, Komenda M, Brunnert M, Bauer L. Comparison of the bioavailability and adhesiveness of different rotigotine transdermal patch formulations. Curr Med Res Opin. 2013 Dec;29(12):1657-62. doi: 10.1185/03007995.2013.841666. Epub 2013 Sep 23.
Results Reference
derived

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Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations

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