NCT00434213

Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA

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 Deficit/Hyperactivity Disorder (ADHD).

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: Noven Therapeutics · Industry
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Daytrana	Methylphenidate Transdermal System (MTS)

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-08-01
• Completion: 2008-07-01
• First posted: 2007-02-13
• Last updated: 2017-04-26
• Results posted: 2009-03-06

Locations

29 sites across 1 country: United States