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Patch adhesiveness study

Patch adhesiveness study - Patch adhesiveness study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36856
Enrollment
52
Registered
2012-10-04
Start date
2012-10-09
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ziekte van Parkinson en rustelood been syndroom Parkinson disease and Restless Legs Syndrome

Interventions

On day 1 and 2, two different rotigotine formulation patches will be apllied for the duration of 24 hours. These patches will be removed on day 2 and 3 and determined what the difference in adhesive

Sponsors

UCB Pharma
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy males and females 18-55 years BMI 19-28 incl

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study

Design outcomes

Primary

MeasureTime frame
Adhesiveness: the average adhesiveness score of 2 days of 24-hour patch application as rated by the investigator Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, skin assessments, physical examination, the C-SSRS

Secondary

MeasureTime frame
Patch adhesiveness over 24 hours of patch application and immediately after patch application

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)