Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Rotigotine transdermal patch

• Registration Number: NCT01338896
• Lead Sponsor: UCB Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-18
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-08-26
• Last Update Posted: 2011-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A-B	Rotigotine transdermal patch	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)
Sequence B-A	Rotigotine transdermal patch	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)

Primary Outcome Measures

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

Secondary Outcome Measures

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