Trial Outcomes & Findings for Study in Elderly Alzheimer's Patients to Assess Skin Tolerability, Irritation With 3, 7-Day Applications of DTP-System (NCT NCT00916383)
NCT ID: NCT00916383
Last Updated: 2021-10-28
Results Overview
Erythema and edema were used to determine skin irritation using a modified Draize scale. Score 0 = no erythema/edema; Score 1 = very slight erythema/edema; Score 2 = well-defined erythema/slight edema; Score 3 = moderate to severe erythema/edema; Score 4 = severe erythema/edema.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Immediately after patch removal
Results posted on
2021-10-28
Participant Flow
The study was conducted at 7 clinical sites during May and June 2009. Patients received 1 placebo patch and 1 Donepezil Transdermal Patch, each applied to opposite sides of the body. The 7-day patches were applied to 1 of 3 consecutive body locations according to 1 of 6 treatment sequences for a total treatment period of 21 days.
Patients diagnosed with Alzheimer's disease who were on a stable course of oral Aricept (10 mg/day) were randomized into the study. Patients discontinued oral Aricept on Day -1 and resumed their original established dose following removal of the last patch.
Participant milestones
| Measure |
All Participants
Patients were randomized to receive the active patch on the left or right side of the body, and the matching placebo patch on the same location on the opposite side of the body, and assigned to one of two sets (left and right of the body for placement of the active patch) of the following 6 treatment sequences. The treatment sequence was repeated for the opposite side of the body for a total of 12 treatment sequences. The 7-day patches were applied to one of 3 consecutive body locations, for a total exposure period of 21 days.
1. Upper Back, Upper Arm, Side of Torso
2. Upper Arm, Side of Torso, Upper Back
3. Side of Torso, Upper Back, Upper Arm
4. Upper Back, Side of Torso, Upper Arm
5. Upper Arm, Upper Back, Side of Torso
6. Side of Torso, Upper Arm, Upper Back
Skin irritation scoring was obtained immediately upon removal of the patch and at 1, 24, and 48 hours after removal.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
All Participants
Patients were randomized to receive the active patch on the left or right side of the body, and the matching placebo patch on the same location on the opposite side of the body, and assigned to one of two sets (left and right of the body for placement of the active patch) of the following 6 treatment sequences. The treatment sequence was repeated for the opposite side of the body for a total of 12 treatment sequences. The 7-day patches were applied to one of 3 consecutive body locations, for a total exposure period of 21 days.
1. Upper Back, Upper Arm, Side of Torso
2. Upper Arm, Side of Torso, Upper Back
3. Side of Torso, Upper Back, Upper Arm
4. Upper Back, Side of Torso, Upper Arm
5. Upper Arm, Upper Back, Side of Torso
6. Side of Torso, Upper Arm, Upper Back
Skin irritation scoring was obtained immediately upon removal of the patch and at 1, 24, and 48 hours after removal.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Study in Elderly Alzheimer's Patients to Assess Skin Tolerability, Irritation With 3, 7-Day Applications of DTP-System
Baseline characteristics by cohort
| Measure |
All Participants
n=49 Participants
All patients received the same study treatment, consisting of 1 placebo patch and 1 Donepezil Transdermal Patch, and all patches were applied to the same body locations according to 1 of 6 treatment sequences. The active patch was applied to either the right or the left side of the body according to the randomization schedule. The treatment sequence was repeated for the opposite side of the body for a total of 12 treatment sequences. The 7-day patches were applied to one of 3 body locations (upper arm, upper back, side of torso) for a total treatment period of 21 days.
|
|---|---|
|
Age, Continuous
All Participants
|
79.5 Years
STANDARD_DEVIATION 6.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately after patch removalPopulation: All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.
Erythema and edema were used to determine skin irritation using a modified Draize scale. Score 0 = no erythema/edema; Score 1 = very slight erythema/edema; Score 2 = well-defined erythema/slight edema; Score 3 = moderate to severe erythema/edema; Score 4 = severe erythema/edema.
Outcome measures
| Measure |
Upper Back
n=48 Participants
DTP-system and placebo patch applied to opposite sides of the upper back.
|
Upper Arm
n=48 Participants
DTP-system and placebo patch applied to the upper part of opposite arms.
|
Side of Torso
n=47 Participants
DTP-system and placebo patch applied to opposite sides of torso.
|
|---|---|---|---|
|
Skin Irritation (Erythema and Edema)
Erythema, Placebo
|
0.9 units on a scale
Standard Deviation 0.85
|
0.7 units on a scale
Standard Deviation 0.76
|
1.1 units on a scale
Standard Deviation 0.89
|
|
Skin Irritation (Erythema and Edema)
Erythema, DTP-System
|
1.0 units on a scale
Standard Deviation 0.75
|
0.8 units on a scale
Standard Deviation 0.75
|
1.0 units on a scale
Standard Deviation 0.85
|
|
Skin Irritation (Erythema and Edema)
Edema, Placebo
|
0.6 units on a scale
Standard Deviation 0.82
|
0.6 units on a scale
Standard Deviation 0.68
|
0.7 units on a scale
Standard Deviation 0.71
|
|
Skin Irritation (Erythema and Edema)
Edema, DTP-System
|
0.6 units on a scale
Standard Deviation 0.76
|
0.5 units on a scale
Standard Deviation 0.68
|
0.7 units on a scale
Standard Deviation 0.73
|
PRIMARY outcome
Timeframe: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)Population: All patients who received patches are included in the analysis.
Erythema was used to determine skin irritation using a modified Draize scale. Score 0 = no erythema; Score 1 = very slight erythema; Score 2 = well-defined erythema; Score 3 = moderate to severe erythema; Score 4 = severe erythema.
Outcome measures
| Measure |
Upper Back
n=49 Participants
DTP-system and placebo patch applied to opposite sides of the upper back.
|
Upper Arm
n=48 Participants
DTP-system and placebo patch applied to the upper part of opposite arms.
|
Side of Torso
n=47 Participants
DTP-system and placebo patch applied to opposite sides of torso.
|
|---|---|---|---|
|
Skin Irritation (Erythema)
1 hour after patch removal, Placebo
|
0.8 units on a scale
Standard Deviation 0.88
|
0.6 units on a scale
Standard Deviation 0.65
|
0.8 units on a scale
Standard Deviation 0.82
|
|
Skin Irritation (Erythema)
1 hour after patch removal, DTP-system
|
0.9 units on a scale
Standard Deviation 0.73
|
0.6 units on a scale
Standard Deviation 0.64
|
0.7 units on a scale
Standard Deviation 0.74
|
|
Skin Irritation (Erythema)
24 hours after patch removal, Placebo
|
0.6 units on a scale
Standard Deviation 0.80
|
0.3 units on a scale
Standard Deviation 0.52
|
0.7 units on a scale
Standard Deviation 0.71
|
|
Skin Irritation (Erythema)
24 hours after patch removal, DTP-system
|
0.4 units on a scale
Standard Deviation 0.62
|
0.4 units on a scale
Standard Deviation 0.57
|
0.4 units on a scale
Standard Deviation 0.62
|
|
Skin Irritation (Erythema)
48 hours after patch removal, Placebo
|
0.3 units on a scale
Standard Deviation 0.54
|
0.2 units on a scale
Standard Deviation 0.46
|
0.4 units on a scale
Standard Deviation 0.65
|
|
Skin Irritation (Erythema)
48 hours after patch removal, DTP-system
|
0.2 units on a scale
Standard Deviation 0.43
|
0.2 units on a scale
Standard Deviation 0.43
|
0.3 units on a scale
Standard Deviation 0.59
|
PRIMARY outcome
Timeframe: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)Population: All patients who received patches are included in the analysis.
Edema was used to determine skin irritation using a modified Draize scale. Score 0 = no edema; Score 1 = very slight edema; Score 2 = slight edema; Score 3 = moderate to severe edema; Score 4 = severe edema.
Outcome measures
| Measure |
Upper Back
n=49 Participants
DTP-system and placebo patch applied to opposite sides of the upper back.
|
Upper Arm
n=48 Participants
DTP-system and placebo patch applied to the upper part of opposite arms.
|
Side of Torso
n=47 Participants
DTP-system and placebo patch applied to opposite sides of torso.
|
|---|---|---|---|
|
Skin Irritation (Edema)
1 hour after patch removal, Placebo
|
0.6 units on a scale
Standard Deviation 0.76
|
0.6 units on a scale
Standard Deviation 0.68
|
0.6 units on a scale
Standard Deviation 0.71
|
|
Skin Irritation (Edema)
1 hour after patch removal, DTP-system
|
0.6 units on a scale
Standard Deviation 0.73
|
0.4 units on a scale
Standard Deviation 0.57
|
0.6 units on a scale
Standard Deviation 0.71
|
|
Skin Irritation (Edema)
24 hours after patch removal, Placebo
|
0.1 units on a scale
Standard Deviation 0.41
|
0.2 units on a scale
Standard Deviation 0.38
|
0.2 units on a scale
Standard Deviation 0.47
|
|
Skin Irritation (Edema)
24 hours after patch removal, DTP-system
|
0.1 units on a scale
Standard Deviation 0.33
|
0.1 units on a scale
Standard Deviation 0.34
|
0.1 units on a scale
Standard Deviation 0.40
|
|
Skin Irritation (Edema)
48 hours after patch removal, Placebo
|
0.0 units on a scale
Standard Deviation 0.14
|
0.0 units on a scale
Standard Deviation 0.15
|
0.1 units on a scale
Standard Deviation 0.25
|
|
Skin Irritation (Edema)
48 hours after patch removal, DTP-system
|
0.0 units on a scale
Standard Deviation 0.14
|
0.0 units on a scale
Standard Deviation 0.15
|
0.0 units on a scale
Standard Deviation 0.29
|
PRIMARY outcome
Timeframe: Immediately after patch removalPopulation: All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.
Papules and vesicles were assessed according to the following scoring criteria: Score 0 = no evidence of papules or vesicles; Score 1 = few papules or vesicles (\< 10) observed on the skin site; Score 2 = more papules or vesicles (≥ 10) observed on \< 50 % of skin site, diffuse or few clusters; Score 3 = many papules or vesicles observed on ≥ 50% of skin site, diffuse or few clusters; Score 4 = many papules or vesicles observed on \> 50% of skin site, with multiple (\> 3) clusters.
Outcome measures
| Measure |
Upper Back
n=48 Participants
DTP-system and placebo patch applied to opposite sides of the upper back.
|
Upper Arm
n=48 Participants
DTP-system and placebo patch applied to the upper part of opposite arms.
|
Side of Torso
n=47 Participants
DTP-system and placebo patch applied to opposite sides of torso.
|
|---|---|---|---|
|
Skin Irritation (Papules and Vesicles)
Placebo, Score >1
|
9 participants
|
5 participants
|
5 participants
|
|
Skin Irritation (Papules and Vesicles)
DTP-System, Score >1
|
7 participants
|
2 participants
|
2 participants
|
|
Skin Irritation (Papules and Vesicles)
Placebo, Score >2
|
2 participants
|
1 participants
|
1 participants
|
|
Skin Irritation (Papules and Vesicles)
DTP-System, Score >2
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)Population: All patients who received patches are included in the analysis.
Papules and vesicles were assessed according to the following scoring criteria: Score 0 = no evidence of papules or vesicles; Score 1 = few papules or vesicles (\< 10) observed on the skin site; Score 2 = more papules or vesicles (≥ 10) observed on \< 50 % of skin site, diffuse or few clusters; Score 3 = many papules or vesicles observed on ≥ 50% of skin site, diffuse or few clusters; Score 4 = many papules or vesicles observed on \> 50% of skin site, with multiple (\> 3) clusters.
Outcome measures
| Measure |
Upper Back
n=49 Participants
DTP-system and placebo patch applied to opposite sides of the upper back.
|
Upper Arm
n=48 Participants
DTP-system and placebo patch applied to the upper part of opposite arms.
|
Side of Torso
n=47 Participants
DTP-system and placebo patch applied to opposite sides of torso.
|
|---|---|---|---|
|
Skin Irritation (Papules and Vesicles)
1 hour after patch removal, Placebo, Score >1
|
9 participants
|
6 participants
|
5 participants
|
|
Skin Irritation (Papules and Vesicles)
1 hour after patch removal, DTP-System, Score >1
|
7 participants
|
2 participants
|
2 participants
|
|
Skin Irritation (Papules and Vesicles)
1 hour after patch removal, Placebo, Score >2
|
2 participants
|
1 participants
|
1 participants
|
|
Skin Irritation (Papules and Vesicles)
1 hour after patch removal, DTP-System, Score >2
|
1 participants
|
0 participants
|
0 participants
|
|
Skin Irritation (Papules and Vesicles)
24 hours after patch removal, Placebo, Score >1
|
5 participants
|
4 participants
|
4 participants
|
|
Skin Irritation (Papules and Vesicles)
24 hours after patch removal, DTP-System, Score >1
|
5 participants
|
2 participants
|
2 participants
|
|
Skin Irritation (Papules and Vesicles)
24 hours after patch removal, Placebo, Score >2
|
2 participants
|
1 participants
|
1 participants
|
|
Skin Irritation (Papules and Vesicles)
24 hours after patch removal, DTP-System, Score >2
|
0 participants
|
0 participants
|
0 participants
|
|
Skin Irritation (Papules and Vesicles)
48 hours after patch removal, Placebo, Score >1
|
5 participants
|
2 participants
|
3 participants
|
|
Skin Irritation (Papules and Vesicles)
48 hours after patch removal, DTP-System, Score >1
|
5 participants
|
1 participants
|
1 participants
|
|
Skin Irritation (Papules and Vesicles)
48 hours after patch removal, Placebo, Score >2
|
2 participants
|
1 participants
|
1 participants
|
|
Skin Irritation (Papules and Vesicles)
48 hours after patch removal, DTP-System, Score >2
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Immediately after patch removalPopulation: All patients who received patches are included in the analysis. Note: The represented data are based on N = 48 for patients who received the placebo patch and the DTP-system on the Upper Back, N = 46 for patients who received the placebo patch on the side of torso, and N = 47 for patients who received the DTP-system on the side of torso.
Other skin effects were assessed according to the following scoring criteria: Score 0 = no other effects observed; Score 1 = slight glazed appearance; Score 2 = marked glazing; Score 3 = glazing with peeling and cracking; Score 4 = glazing with fissures; Score 5 = film of dried serous exudate covering all or part of the patch site; Score 6 = small petechial erosions and/or scabs.
Outcome measures
| Measure |
Upper Back
n=48 Participants
DTP-system and placebo patch applied to opposite sides of the upper back.
|
Upper Arm
n=48 Participants
DTP-system and placebo patch applied to the upper part of opposite arms.
|
Side of Torso
n=47 Participants
DTP-system and placebo patch applied to opposite sides of torso.
|
|---|---|---|---|
|
Skin Irritation (Other Skin Effects)
Placebo, Score ≥1
|
10 participants
|
9 participants
|
8 participants
|
|
Skin Irritation (Other Skin Effects)
DTP-System, Score ≥1
|
8 participants
|
7 participants
|
8 participants
|
|
Skin Irritation (Other Skin Effects)
Placebo, Score =6
|
2 participants
|
6 participants
|
0 participants
|
|
Skin Irritation (Other Skin Effects)
DTP-System, Score =6
|
2 participants
|
4 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 1, 24, and 48 hours after patch removal (Days 8-10; Days 15-17; Days 22-24)Population: All patients who received patches are included in the analysis.
Other skin effects were assessed according to the following scoring criteria: Score 0 = no other effects observed; Score 1 = slight glazed appearance; Score 2 = marked glazing; Score 3 = glazing with peeling and cracking; Score 4 = glazing with fissures; Score 5 = film of dried serous exudate covering all or part of the patch site; Score 6 = small petechial erosions and/or scabs.
Outcome measures
| Measure |
Upper Back
n=49 Participants
DTP-system and placebo patch applied to opposite sides of the upper back.
|
Upper Arm
n=48 Participants
DTP-system and placebo patch applied to the upper part of opposite arms.
|
Side of Torso
n=47 Participants
DTP-system and placebo patch applied to opposite sides of torso.
|
|---|---|---|---|
|
Skin Irritation (Other Skin Effects)
1 hour after patch removal, Placebo, Score ≥1
|
10 participants
|
9 participants
|
8 participants
|
|
Skin Irritation (Other Skin Effects)
1 hour after patch removal, DTP-System, Score ≥1
|
9 participants
|
7 participants
|
8 participants
|
|
Skin Irritation (Other Skin Effects)
1 hour after patch removal, Placebo, Score =6
|
2 participants
|
6 participants
|
0 participants
|
|
Skin Irritation (Other Skin Effects)
1 hour after patch removal, DTP-System, Score =6
|
3 participants
|
4 participants
|
2 participants
|
|
Skin Irritation (Other Skin Effects)
24 hours after patch removal, Placebo, Score ≥1
|
3 participants
|
7 participants
|
3 participants
|
|
Skin Irritation (Other Skin Effects)
24 hours after patch removal, DTP-System, Score ≥1
|
3 participants
|
6 participants
|
3 participants
|
|
Skin Irritation (Other Skin Effects)
24 hours after patch removal, Placebo, Score =6
|
2 participants
|
5 participants
|
1 participants
|
|
Skin Irritation (Other Skin Effects)
24 hours after patch removal, DTP-System, Score =6
|
2 participants
|
3 participants
|
2 participants
|
|
Skin Irritation (Other Skin Effects)
48 hours after patch removal, Placebo, Score ≥1
|
2 participants
|
6 participants
|
1 participants
|
|
Skin Irritation (Other Skin Effects)
48 hours after patch removal, DTP-System, Score ≥1
|
2 participants
|
5 participants
|
2 participants
|
|
Skin Irritation (Other Skin Effects)
48 hours after patch removal, Placebo, Score =6
|
2 participants
|
5 participants
|
1 participants
|
|
Skin Irritation (Other Skin Effects)
48 hours after patch removal, DTP-System, Score =6
|
2 participants
|
3 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Safety was assessed throughout the study. Adhesion was assessed daily and immediately prior to patch removal on Days 8, 15, and 22.Population: Percent of Patients with Adhesion Scores \<2 by Application Day
See Adverse Event section for Safety assessment. Adhesion was assessed according to the following scoring criteria: Score 0 = approximately \> 90% adhered (essentially no lift off the skin); Score 1 = approximately 75% to \< 90% adhered (some edges only lifting off the skin); Score 2 = approximately 50% to \< 75% adhered (less than half of the system lifting off the skin); Score of 3 = approximately \< 50% adhered but not detached (more than half of the system lifting off the skin without falling off); Score of 4 = Patch-system detached (patch /overlay completely off the skin).
Outcome measures
| Measure |
Upper Back
n=49 Participants
DTP-system and placebo patch applied to opposite sides of the upper back.
|
Upper Arm
n=48 Participants
DTP-system and placebo patch applied to the upper part of opposite arms.
|
Side of Torso
n=48 Participants
DTP-system and placebo patch applied to opposite sides of torso.
|
|---|---|---|---|
|
Safety, Tolerability, and Adhesion
Placebo - Worst adhesion score over 7 days
|
89.6 percentage of patients with scores <2
|
93.8 percentage of patients with scores <2
|
93.8 percentage of patients with scores <2
|
|
Safety, Tolerability, and Adhesion
DTP system - Worst adhesion score over 7 days
|
83.4 percentage of patients with scores <2
|
89.3 percentage of patients with scores <2
|
85.4 percentage of patients with scores <2
|
|
Safety, Tolerability, and Adhesion
Placebo - Day 1
|
97.9 percentage of patients with scores <2
|
100 percentage of patients with scores <2
|
100 percentage of patients with scores <2
|
|
Safety, Tolerability, and Adhesion
DTP system - Day 1
|
95.8 percentage of patients with scores <2
|
97.9 percentage of patients with scores <2
|
100 percentage of patients with scores <2
|
|
Safety, Tolerability, and Adhesion
Placebo - Day 2
|
100 percentage of patients with scores <2
|
100 percentage of patients with scores <2
|
100 percentage of patients with scores <2
|
|
Safety, Tolerability, and Adhesion
DTP system - Day 2
|
97.8 percentage of patients with scores <2
|
97.8 percentage of patients with scores <2
|
97.9 percentage of patients with scores <2
|
|
Safety, Tolerability, and Adhesion
Placebo - Day 3
|
100 percentage of patients with scores <2
|
97.9 percentage of patients with scores <2
|
100 percentage of patients with scores <2
|
|
Safety, Tolerability, and Adhesion
DTP system - Day 3
|
95.7 percentage of patients with scores <2
|
100 percentage of patients with scores <2
|
95.8 percentage of patients with scores <2
|
|
Safety, Tolerability, and Adhesion
Placebo - Day 4
|
100 percentage of patients with scores <2
|
95.8 percentage of patients with scores <2
|
100 percentage of patients with scores <2
|
|
Safety, Tolerability, and Adhesion
DTP system - Day 4
|
95.6 percentage of patients with scores <2
|
97.7 percentage of patients with scores <2
|
97.8 percentage of patients with scores <2
|
|
Safety, Tolerability, and Adhesion
Placebo - Day 5
|
97.9 percentage of patients with scores <2
|
100 percentage of patients with scores <2
|
100 percentage of patients with scores <2
|
|
Safety, Tolerability, and Adhesion
DTP system - Day 5
|
93.2 percentage of patients with scores <2
|
100 percentage of patients with scores <2
|
93.3 percentage of patients with scores <2
|
|
Safety, Tolerability, and Adhesion
Placebo - Day 6
|
93.5 percentage of patients with scores <2
|
97.8 percentage of patients with scores <2
|
97.9 percentage of patients with scores <2
|
|
Safety, Tolerability, and Adhesion
DTP system - Day 6
|
95.4 percentage of patients with scores <2
|
95.4 percentage of patients with scores <2
|
95.5 percentage of patients with scores <2
|
|
Safety, Tolerability, and Adhesion
Placebo - Day 7
|
91.3 percentage of patients with scores <2
|
97.8 percentage of patients with scores <2
|
95.8 percentage of patients with scores <2
|
|
Safety, Tolerability, and Adhesion
DTP system - Day 7
|
93.1 percentage of patients with scores <2
|
97.6 percentage of patients with scores <2
|
93.0 percentage of patients with scores <2
|
Adverse Events
Systemic Events
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
DTP-system
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo Patch
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Systemic Events
n=49 participants at risk
All enrolled patients
|
DTP-system
n=49 participants at risk
Localized events
|
Placebo Patch
n=49 participants at risk
Localized events
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
|
0.00%
0/49 • Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
|
0.00%
0/49 • Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
|
0.00%
0/49 • Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
|
0.00%
0/49 • Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/49 • Number of events 1 • Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
|
0.00%
0/49 • Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
|
0.00%
0/49 • Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
|
Other adverse events
| Measure |
Systemic Events
n=49 participants at risk
All enrolled patients
|
DTP-system
n=49 participants at risk
Localized events
|
Placebo Patch
n=49 participants at risk
Localized events
|
|---|---|---|---|
|
General disorders
Application site pruritus
|
0.00%
0/49 • Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
|
28.6%
14/49 • Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
|
30.6%
15/49 • Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
|
|
Psychiatric disorders
Confusional State
|
6.1%
3/49 • Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
|
0.00%
0/49 • Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
|
0.00%
0/49 • Adverse event data were collected from the time the patient signed the Informed Consent Form until study discharge (Day 24) (3 days after removal of the last patch).
All patients who received study drug were included in the safety summaries. Adverse events (AEs) collected prior to the patient receiving drug were considered baseline signs or symptoms. Any baseline sign or symptom that worsened during the course of the study was considered a treatment-emergent AE.
|
Additional Information
Director of Clinical Trials
Teikoku Pharma USA, Inc.
Phone: (408) 501-1821
Results disclosure agreements
- Principal investigator is a sponsor employee An Institution Publication may be published provided that it does not disclose Confidential Information other than the study results from the Institution's study data. The proposed Institution Publication shall be submitted to sponsor for review and comment at least 30 days prior to submitting it to a third party. If sponsor requests a delay in order to file patent applications, the Institution Publication may be delayed for submission to a third party for up to 120 days after sponsor request.
- Publication restrictions are in place
Restriction type: OTHER