Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT01338896
First received: April 18, 2011
Last updated: August 26, 2011
Last verified: July 2011

April 18, 2011
August 26, 2011
April 2011
May 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
The international patch adhesiveness score
Same as current
Complete list of historical versions of study NCT01338896 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    The international patch adhesiveness score
  • 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 ] [ Designated as safety issue: No ]
    The international patch adhesiveness score
Same as current
Not Provided
Not Provided
 
Study to Compare Adhesiveness of Two Different Rotigotine Patch Formulations
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
Drug: Rotigotine transdermal patch
8 mg/24 h, transdermal patch 8 mg/24 h, 2 days
Other Name: Neupro
  • 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)
    Intervention: Drug: Rotigotine transdermal patch
  • 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)
    Intervention: Drug: Rotigotine transdermal patch
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
June 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany,   United Kingdom
 
NCT01338896
SP1066, 2010-024250-11
No
UCB Pharma
UCB Pharma
Not Provided
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
UCB Pharma
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP