Trial Outcomes & Findings for A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease (NCT NCT02230904)
NCT ID: NCT02230904
Last Updated: 2015-11-02
Results Overview
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012). * 0 = \> 95 - 100 % of the patch area adheres * 1 = \> 90 - 95 % of the patch adheres * 2 = \> 85 - 90 % of the patch adheres * 3 = \> 80 - 85 % of the patch adheres * 4 = \> 75 - 80 % of the patch adheres * 5 = \> 70 - 75 % of the patch adheres * 6 = ≥ 50 - 70 % of the patch adheres * 7 = \< 50 % of the patch adheres * 8 = Patch completely detached The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline. The average of patches 1 and 2 is presented by Treatment Arm below.
COMPLETED
PHASE1
57 participants
Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5
2015-11-02
Participant Flow
This study started to enroll subjects in September 2014 in Germany and concluded in December 2014.
Participant Flow refers to the Randomized Set.
Participant milestones
| Measure |
Treatment Arm A-B
4 day treatment (Treatment A for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)
|
Treatment Arm B-A
4 day treatment (Treatment B for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Treatment Arm A-B
4 day treatment (Treatment A for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)
|
Treatment Arm B-A
4 day treatment (Treatment B for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
|
|---|---|---|
|
Overall Study
Safety follow up could not take place
|
0
|
1
|
Baseline Characteristics
A Study to Compare the Adhesiveness of 2 Different Rotigotine Patches Used for the Treatment of Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Treatment Arm A-B
n=29 Participants
4 day treatment (Treatment A for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)
|
Treatment Arm B-A
n=28 Participants
4 day treatment (Treatment B for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
|
Total Title
n=57 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
69.6 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
68.4 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Patch adhesiveness was measured after 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5Population: Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012). * 0 = \> 95 - 100 % of the patch area adheres * 1 = \> 90 - 95 % of the patch adheres * 2 = \> 85 - 90 % of the patch adheres * 3 = \> 80 - 85 % of the patch adheres * 4 = \> 75 - 80 % of the patch adheres * 5 = \> 70 - 75 % of the patch adheres * 6 = ≥ 50 - 70 % of the patch adheres * 7 = \< 50 % of the patch adheres * 8 = Patch completely detached The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline. The average of patches 1 and 2 is presented by Treatment Arm below.
Outcome measures
| Measure |
Treatment A
n=52 Participants
Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
|
Treatment B
n=52 Participants
Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
|
|---|---|---|
|
Change in Average Adhesiveness Score of 2 Days of 24 Hours Patch Application as Rated by the Investigator (or Designee) Assessed According to the EMA Draft Guideline
|
1.04 units on a scale
Standard Deviation 1.33
|
2.15 units on a scale
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4Population: Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012). * 0 = \>95 - 100 % of the patch area adheres * 1 = \>90 - 95 % of the patch adheres * 2 = \>85 - 90 % of the patch adheres * 3 = \>80 - 85 % of the patch adheres * 4 = \>75 - 80 % of the patch adheres * 5 = \>70 - 75 % of the patch adheres * 6 = ≥50 - 70 % of the patch adheres * 7 = \<50 % of the patch adheres * 8 = Patch completely detached The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline.
Outcome measures
| Measure |
Treatment A
n=52 patches
Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
|
Treatment B
n=52 patches
Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
|
|---|---|---|
|
Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1
> 95 %
|
65.4 percentage of patches
|
46.2 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1
> 90 % - 95 %
|
11.5 percentage of patches
|
17.3 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1
> 85 % - 90 %
|
7.7 percentage of patches
|
5.8 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1
> 80 % - 85 %
|
3.8 percentage of patches
|
9.6 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1
> 75 % - 80 %
|
3.8 percentage of patches
|
1.9 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1
> 70 % - 75 %
|
0 percentage of patches
|
1.9 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1
<= 70 %
|
7.7 percentage of patches
|
17.3 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator or Designee 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 1
Missing
|
0 percentage of patches
|
0 percentage of patches
|
SECONDARY outcome
Timeframe: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5Population: Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches (EMA/CHMMP/QWP/911254/2011, 2012). * 0 = \>95 - 100 % of the patch area adheres * 1 = \>90 - 95 % of the patch adheres * 2 = \>85 - 90 % of the patch adheres * 3 = \>80 - 85 % of the patch adheres * 4 = \>75 - 80 % of the patch adheres * 5 = \>70 - 75 % of the patch adheres * 6 = ≥50 - 70 % of the patch adheres * 7 = \<50 % of the patch adheres * 8 = Patch completely detached The recorded scores 6, 7, and 8 were combined in order to create a cumulative group "less than or equal to 70 % adhered or patch detachment" which was regarded as significant patch adhesion failure in the draft EMA guideline.
Outcome measures
| Measure |
Treatment A
n=52 patches
Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
|
Treatment B
n=52 patches
Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
|
|---|---|---|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2
> 95 %
|
71.2 percentage of patches
|
36.5 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2
> 90 % - 95 %
|
5.8 percentage of patches
|
7.7 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2
> 85 % - 90 %
|
3.8 percentage of patches
|
9.6 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2
> 80 % - 85 %
|
3.8 percentage of patches
|
9.6 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2
> 75 % - 80 %
|
3.8 percentage of patches
|
9.6 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2
> 70 % - 75 %
|
1.9 percentage of patches
|
3.8 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2
<= 70 %
|
9.6 percentage of patches
|
23.1 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the EMA Draft Guideline for Patch 2
Missing
|
0 percentage of patches
|
0 percentage of patches
|
SECONDARY outcome
Timeframe: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4Population: Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores: * 0 (\>95-100% of patch adheres) \>\> 0 (FDA/CDER) * 1 (\>90-95% of patch adheres) \>\> 0 (FDA/CDER) * 2 (\>85-90% of patch adheres) \>\> 1 (FDA/CDER) * 3 (\>80-85% of patch adheres) \>\> 1 (FDA/CDER) * 4 ( \>75-80% of patch adheres) \>\> 1 (FDA/CDER) * 5 (\>70-75% of patch adheres) \>\> 2 (FDA/CDER) * 6 (≥50-70% of patch adheres) \>\> 2 (FDA/CDER) * 7 (\<50 % of patch adheres) \>\> 3 (FDA/CDER) * 8 (Patch completely detached) \>\> 4 (FDA/CDER) Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies.
Outcome measures
| Measure |
Treatment A
n=52 patches
Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
|
Treatment B
n=52 patches
Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
|
|---|---|---|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1
75 % -< 90 %
|
15.4 percentage of patches
|
17.3 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1
50 % -< 75 %
|
1.9 percentage of patches
|
11.5 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1
< 50 %
|
3.8 percentage of patches
|
0 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1
Detached
|
1.9 percentage of patches
|
7.7 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1
Missing
|
0 percentage of patches
|
0 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 1
>= 90 %
|
76.9 percentage of patches
|
63.5 percentage of patches
|
SECONDARY outcome
Timeframe: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5Population: Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores: * 0 (\>95-100% of patch adheres) \>\> 0 (FDA/CDER) * 1 (\>90-95% of patch adheres) \>\> 0 (FDA/CDER) * 2 (\>85-90% of patch adheres) \>\> 1 (FDA/CDER) * 3 (\>80-85% of patch adheres) \>\> 1 (FDA/CDER) * 4 ( \>75-80% of patch adheres) \>\> 1 (FDA/CDER) * 5 (\>70-75% of patch adheres) \>\> 2 (FDA/CDER) * 6 (≥50-70% of patch adheres) \>\> 2 (FDA/CDER) * 7 (\<50 % of patch adheres) \>\> 3 (FDA/CDER) * 8 (Patch completely detached) \>\> 4 (FDA/CDER) Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies.
Outcome measures
| Measure |
Treatment A
n=52 patches
Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
|
Treatment B
n=52 patches
Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
|
|---|---|---|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2
>= 90 %
|
76.9 percentage of patches
|
44.2 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2
75 % -< 90 %
|
11.5 percentage of patches
|
28.8 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2
50 % -< 75 %
|
3.8 percentage of patches
|
17.3 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2
< 50 %
|
7.7 percentage of patches
|
3.8 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2
Detached
|
0 percentage of patches
|
5.8 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Investigator 24 Hours After Patch Application According to the FDA/Center for Drug Evaluation and Research (CDER) Score for Patch 2
Missing
|
0 percentage of patches
|
0 percentage of patches
|
SECONDARY outcome
Timeframe: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2 and 4Population: Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.
The subject assessed the patch adhesiveness by using the following score: * 0 = Satisfied with adhesiveness * 1 = Moderately satisfied with adhesiveness * 2 = Moderately unsatisfied with adhesiveness * 3 = Unsatisfied with adhesiveness
Outcome measures
| Measure |
Treatment A
n=52 patches
Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
|
Treatment B
n=52 patches
Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
|
|---|---|---|
|
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1
0 = Satisfied with adhesiveness
|
75.0 percentage of patches
|
65.4 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1
1 = Moderately satisfied with adhesiveness
|
17.3 percentage of patches
|
13.5 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1
2 = Moderately unsatisfied with adhesiveness
|
3.8 percentage of patches
|
9.6 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 1
3 = Unsatisfied with adhesiveness
|
3.8 percentage of patches
|
11.5 percentage of patches
|
SECONDARY outcome
Timeframe: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 3 and 5Population: Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.
The subject assessed the patch adhesiveness by using the following score: * 0 = Satisfied with adhesiveness * 1 = Moderately satisfied with adhesiveness * 2 = Moderately unsatisfied with adhesiveness * 3 = Unsatisfied with adhesiveness
Outcome measures
| Measure |
Treatment A
n=52 patches
Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
|
Treatment B
n=52 patches
Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
|
|---|---|---|
|
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2
0 = Satisfied with adhesiveness
|
73.1 percentage of patches
|
59.6 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2
1 = Moderately satisfied with adhesiveness
|
15.4 percentage of patches
|
26.9 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2
2 = Moderately unsatisfied with adhesiveness
|
9.6 percentage of patches
|
5.8 percentage of patches
|
|
Patch Adhesiveness Per Day as Rated by the Subject 24 Hours After Patch Application for Patch 2
3 = Unsatisfied with adhesiveness
|
1.9 percentage of patches
|
7.7 percentage of patches
|
SECONDARY outcome
Timeframe: Patch adhesiveness was measured 24 hours (±1 hour) after previous patch application on Day 2, 3, 4 and 5Population: Per Protocol Set (PPS), which was defined as all subjects who had at least 1 patch adhesiveness assessment after 24 hours of patch application by the investigator (or designee) for both treatments.
The assessment was performed according to the adhesion score adapted from the EMA draft guideline on quality of transdermal patches . Afterwards, EMA scores were translated into FDA/CDER scores: * 0 (\>95-100% of patch adheres) \>\> 0 (FDA/CDER) * 1 (\>90-95% of patch adheres) \>\> 0 (FDA/CDER) * 2 (\>85-90% of patch adheres) \>\> 1 (FDA/CDER) * 3 (\>80-85% of patch adheres) \>\> 1 (FDA/CDER) * 4 ( \>75-80% of patch adheres) \>\> 1 (FDA/CDER) * 5 (\>70-75% of patch adheres) \>\> 2 (FDA/CDER) * 6 (≥50-70% of patch adheres) \>\> 2 (FDA/CDER) * 7 (\<50 % of patch adheres) \>\> 3 (FDA/CDER) * 8 (Patch completely detached) \>\> 4 (FDA/CDER) Due to a slight mismatch of limits between FDA scores 0 and 1 as compared to EMA scores 1 and 2, the theoretical value of exactly 90 % of adh. fell into score 1 with the FDA scoring. A similar limit mismatch occured at exactly 75 %. These mismatches may have resulted in a slightly worse estimation of the adh. with the FDA score as compared to previous adh. studies.
Outcome measures
| Measure |
Treatment A
n=52 Participants
Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
|
Treatment B
n=52 Participants
Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
|
|---|---|---|
|
Change in Average Patch Adhesiveness Score of 2 Days of 24 Hour Patch Application as Rated by the Investigator (or Designee), Assessed According to the FDA/Center for Drug Evaluation and Research (CDER) Score
|
0.40 units on a scale
Standard Deviation 0.60
|
0.85 units on a scale
Standard Deviation 1.03
|
Adverse Events
Treatment A
Treatment B
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=57 participants at risk
Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
|
Treatment B
n=57 participants at risk
Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.3%
7/57 • Number of events 8 • Treatment-emergent Adverse Events were collected from Visit 2 (Day 1) up to the Safety Follow-up Visit (Day 12).
Adverse Events refer to the Safety Set, consisting of all randomized subjects who entered the study and received at least 1 dose of study medication.
|
1.8%
1/57 • Number of events 1 • Treatment-emergent Adverse Events were collected from Visit 2 (Day 1) up to the Safety Follow-up Visit (Day 12).
Adverse Events refer to the Safety Set, consisting of all randomized subjects who entered the study and received at least 1 dose of study medication.
|
Additional Information
UCB (Study Director)
UCB Clinical Trial Call Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60