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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024250-11 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A-B | Experimental | 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 | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotigotine transdermal patch | Drug | 8 mg/24 h, transdermal patch 8 mg/24 h, 2 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patch adhesiveness of second treatment day as rated by the investigator (or designee) 24 hours after patch application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innsbruck | Austria | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24006953 | Derived | 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. |
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The international patch adhesiveness score |
| after 24 hour of patch application |
| Vienna |
| Austria |
| Alzenau in Unterfranken | Germany |
| Berlin | Germany |
| Bochum | Germany |
| Böblingen | Germany |
| Cologne | Germany |
| Gera | Germany |
| Karlstadt am Main | Germany |
| Stuttgart | Germany |
| Wolfach | Germany |
| Blackpool | United Kingdom |
| Derby | United Kingdom |
| Liverpool | United Kingdom |
| Newcastle upon Tyne | United Kingdom |
| Norwich | United Kingdom |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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