Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434213
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2007-02-12
Brief Title:
Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA
Sponsor:
Noven Therapeutics
Organization:
Noven Therapeutics
Study Overview
Official Title:
A Phase IV Multi-center Open-label Study of DAYTRANA Methylphenidate Transdermal System MTS to Characterize the Dermal Reactions in Pediatric Patients Aged 6-12 With Attention DeficitHyperactivity Disorder ADHD
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study designed to characterize the dermal response of DAYTRANA Subjects will visit the study site over a period of approximately 14 weeks
Detailed Description:
This is a study designed to characterize the dermal response of DAYTRANA Subjects will visit the study site over a period of approximately 14 weeks Subjects will be titrated to an optimum dose of study treatment and assessed for safety and efficacy Dermal response will be evaluated at each visit by the investigator Subjects with high dermal response scores or scores that persist at the same application site and have no improvement after up to 4 evaluations not to exceed a two week period will be discontinued from the study and referred to a study specific dermatologist for specialized skin sensitivity skin patch testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None