Trial Outcomes & Findings for Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA (NCT NCT00434213)
NCT ID: NCT00434213
Last Updated: 2017-04-26
Results Overview
Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
309 participants
Primary outcome timeframe
7 weeks
Results posted on
2017-04-26
Participant Flow
Participant milestones
| Measure |
Daytrana
Methylphenidate Transdermal System (MTS)
|
|---|---|
|
Overall Study
STARTED
|
309
|
|
Overall Study
COMPLETED
|
260
|
|
Overall Study
NOT COMPLETED
|
49
|
Reasons for withdrawal
| Measure |
Daytrana
Methylphenidate Transdermal System (MTS)
|
|---|---|
|
Overall Study
Adverse Event
|
12
|
|
Overall Study
Lack of Efficacy
|
9
|
|
Overall Study
Lost to Follow-up
|
14
|
|
Overall Study
Withdrawal by Subject
|
7
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Unable to comply with study visit window
|
2
|
|
Overall Study
Application site reaction
|
1
|
|
Overall Study
Non-compliant to study schedule
|
1
|
Baseline Characteristics
Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA
Baseline characteristics by cohort
| Measure |
Daytrana
n=309 Participants
Methylphenidate Transdermal System (MTS)
|
|---|---|
|
Age, Categorical
<=18 years
|
309 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
9.1 years
STANDARD_DEVIATION 1.95 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
218 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
309 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: Safety population
Dermal reactions were graded on a scale ranging from 0 (no irritation) to 7 (strong reaction) for observed findings of erythema, edema, papules, and vesicles.
Outcome measures
| Measure |
Daytrana
n=305 Participants
Methylphenidate Transdermal System (MTS)
|
|---|---|
|
Dermal Reactions
0 (no evidence of irritation)
|
46 Participants
|
|
Dermal Reactions
1 (minimal erythema)
|
97 Participants
|
|
Dermal Reactions
2 (definite eythema)
|
151 Participants
|
|
Dermal Reactions
3 (erythema and papules)
|
6 Participants
|
|
Dermal Reactions
4 (definite edema)
|
3 Participants
|
|
Dermal Reactions
5 (erythema, edema, and papules)
|
0 Participants
|
|
Dermal Reactions
6 (vesicular eruption)
|
0 Participants
|
|
Dermal Reactions
7 (strong reaction beyond test site)
|
0 Participants
|
|
Dermal Reactions
No dermal evaluation
|
2 Participants
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: Safety population
Contact sensitization to methylphenidate through skin patch testing.
Outcome measures
| Measure |
Daytrana
n=305 Participants
Methylphenidate Transdermal System (MTS)
|
|---|---|
|
Contact Sensitization to Methylphenidate
|
1 Participants
|
Adverse Events
Daytrana
Serious events: 0 serious events
Other events: 242 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Daytrana
n=305 participants at risk
Methylphenidate Transdermal System (MTS)
|
|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.1%
95/305 • Number of events 99
|
|
Nervous system disorders
Headache
|
16.4%
50/305 • Number of events 64
|
|
Psychiatric disorders
Insomnia
|
10.5%
32/305 • Number of events 34
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.5%
26/305 • Number of events 36
|
|
Psychiatric disorders
Affect lability
|
7.2%
22/305 • Number of events 26
|
|
Gastrointestinal disorders
Nausea
|
7.2%
22/305 • Number of events 27
|
|
Infections and infestations
Upper respiratory tract infection
|
6.6%
20/305 • Number of events 20
|
|
Psychiatric disorders
Irritability
|
5.9%
18/305 • Number of events 18
|
Additional Information
Amaury Sanchez, Sr. Manager, Regulatory Affairs
Noven Pharmaceuticals, Inc.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after SPONSOR confirms there shall be no multicenter Study publication, the INSTITUTION and/or such PRINCIPAL INVESTIGATOR may publish the results from the INSTITUTION site individually.
- Publication restrictions are in place
Restriction type: OTHER