Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338896
• Other study ID #: SP1066
• Secondary ID: 2010-024250-11
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2011
• Last updated: August 26, 2011
• Start date: April 2011
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Rotigotine transdermal patch
8 mg/24 h, transdermal patch 8 mg/24 h, 2 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

Austria,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average adhesiveness score of 2 days of 24 hours patch application as rated by the investigator (or designee)	The international patch adhesiveness score	2 days of 24 hours patch application	No
Secondary	Patch adhesiveness of first treatment day as rated by the investigator (or designee) 24 hours after patch application	The international patch adhesiveness score	after 24 hours of patch application	No
Secondary	Patch adhesiveness of second treatment day as rated by the investigator (or designee) 24 hours after patch application	The international patch adhesiveness score	after 24 hour of patch application	No