Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT04183634
Status:
TERMINATED
Last Update Posted:
2020-11-09
First Post:
2019-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.
Sponsor:
Sandoz
Organization:
Study Overview
Official Title:
An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application.
Detailed Description:
The objective of this clinical trial is to evaluate the adhesion of the test product when compared to the reference product following a single transdermal application.
The following evaluations will be assessed as "yes" or "no":
* Cold flow (dark ring formed around the patch)
* Patch movement/displacement
* Patch wrinkling
* Residue formation (at patch application on the release liner and at patch removal on the skin) Safety and tolerability of a single dose application of a patch containing 18 mg rotigotine (Test) against a patch containing 18 mg rotigotine (Reference) will be evaluated in terms of vital signs and AEs.
AEs and clinical tolerability will be monitored at all clinical trial visits. The safety evaluation will be based upon the review of the individual values (potentially clinically important abnormalities) and descriptive statistics (summary tables, graphics).
As additional safety parameters for the clinical trial physical examination findings, clinical laboratory parameters, and 12-lead ECGs will be assessed at the screening and follow-up.
The following evaluations will be assessed as "yes" or "no":
* Cold flow (dark ring formed around the patch)
* Patch movement/displacement
* Patch wrinkling
* Residue formation (at patch application on the release liner and at patch removal on the skin) Safety and tolerability of a single dose application of a patch containing 18 mg rotigotine (Test) against a patch containing 18 mg rotigotine (Reference) will be evaluated in terms of vital signs and AEs.
AEs and clinical tolerability will be monitored at all clinical trial visits. The safety evaluation will be based upon the review of the individual values (potentially clinically important abnormalities) and descriptive statistics (summary tables, graphics).
As additional safety parameters for the clinical trial physical examination findings, clinical laboratory parameters, and 12-lead ECGs will be assessed at the screening and follow-up.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: