Back to resultsAn Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.
Primary Purpose
Parkinson Disease
Status
Terminated
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Rotigotine TTS (Test)
Neupro (Reference)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring adhesiveness
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with idiopathic Parkinson's Disease assessed as eligible for receiving 18 mg/IRR 8 mg/24 h rotigotine via the test and the reference product each on subsequent days in order to reach the dose of active substance at the individual routine medical care. Patients should be on a stable rotigotine dose of at least 8 mg/24 h for at least 1 week before screening.
Exclusion Criteria:
- Current participation in another clinical trial, participation in another clinical study (i.e. last protocol specified visit) involving another IMP within at least 28 days prior to first application or previous participation in this clinical Trial
- History or presence of clinically significant dermatologic diseases or conditions, such as atopy, neurodermatitis, contact allergy, eczema, psoriasis, vitiligo, melanoma, squamous cell carcinoma.
- History or presence of any dermatological condition or skin sensitivity that could affect IMP Absorption
- History of clinically relevant (severe) hypersensitivity to the active pharmaceutical ingredient or substances of the same class or one of the excipients, clinically relevant allergy.
Sites / Locations
- Sandoz Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Period 1: Rotigotine TTS (Test) - Period 2: Neupro (Reference)
Period 1: Neupro (Reference) - Period 2: Rotigotine TTS (Test)
Arm Description
For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h
For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h
Outcomes
Primary Outcome Measures
Patch Adhesion
Patch Adhesion will be measured as the percentage of area that remained adhered after 24 hours of patch application.
Secondary Outcome Measures
Number of patients with cold flow
Cold flow is defined as dark ring formed around the patch
Number of patients with patch movement/displacement
Number of patients with patch wrinkling
Number of patients with patch residue formation
Patch residue formation is assessed at patch application on the release liner and at patch removal on the skin.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04183634
Brief Title
An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.
Official Title
An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Company Decision
Study Start Date
December 3, 2019 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
March 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sandoz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
adhesiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Period 1: Rotigotine TTS (Test) - Period 2: Neupro (Reference)
Arm Type
Experimental
Arm Description
For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h
Arm Title
Period 1: Neupro (Reference) - Period 2: Rotigotine TTS (Test)
Arm Type
Active Comparator
Arm Description
For each period: an 18 mg transdermal patch to deliver 8 mg/24h will be applied for 24 h
Intervention Type
Drug
Intervention Name(s)
Rotigotine TTS (Test)
Intervention Description
Transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24.
Intervention Type
Drug
Intervention Name(s)
Neupro (Reference)
Intervention Description
Neupro®: transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24 h.
Primary Outcome Measure Information:
Title
Patch Adhesion
Description
Patch Adhesion will be measured as the percentage of area that remained adhered after 24 hours of patch application.
Time Frame
24 hours in each Treatment Period
Secondary Outcome Measure Information:
Title
Number of patients with cold flow
Description
Cold flow is defined as dark ring formed around the patch
Time Frame
24 hours in each Treatment Period
Title
Number of patients with patch movement/displacement
Time Frame
24 hours in each Treatment Period
Title
Number of patients with patch wrinkling
Time Frame
24 hours in each Treatment Period
Title
Number of patients with patch residue formation
Description
Patch residue formation is assessed at patch application on the release liner and at patch removal on the skin.
Time Frame
24 hours in each Treatment Period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with idiopathic Parkinson's Disease assessed as eligible for receiving 18 mg/IRR 8 mg/24 h rotigotine via the test and the reference product each on subsequent days in order to reach the dose of active substance at the individual routine medical care. Patients should be on a stable rotigotine dose of at least 8 mg/24 h for at least 1 week before screening.
Exclusion Criteria:
Current participation in another clinical trial, participation in another clinical study (i.e. last protocol specified visit) involving another IMP within at least 28 days prior to first application or previous participation in this clinical Trial
History or presence of clinically significant dermatologic diseases or conditions, such as atopy, neurodermatitis, contact allergy, eczema, psoriasis, vitiligo, melanoma, squamous cell carcinoma.
History or presence of any dermatological condition or skin sensitivity that could affect IMP Absorption
History of clinically relevant (severe) hypersensitivity to the active pharmaceutical ingredient or substances of the same class or one of the excipients, clinically relevant allergy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandoz
Organizational Affiliation
Sandoz
Official's Role
Study Director
Facility Information:
Facility Name
Sandoz Investigative Site
City
Hamburg
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.
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