Status:
COMPLETED
Characterization of Dermal Reactions in Pediatric Patients With ADHD Using DAYTRANA
Lead Sponsor:
Noven Therapeutics
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
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 st...
Eligibility Criteria
Inclusion
- Must sign informed consent.
- Male or female 6-12 years old.
- Negative pregnancy test.
- Meet Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD.
- No co-morbid illness that could affect safety, tolerability or interfere with participation.
- Blood pressure (BP) within the 95th percentile for age, gender, and height.
- Willing and able to comply with all the requirements defined in protocol.
Exclusion
- Current controlled (requiring a restricted medication) or uncontrolled co-morbid psychiatric diagnosis (except Oppositional Defiant Disorder \[ODD\]).
- At risk for suicidal or violent behavior towards self or others.
- History of a suicide attempt.
- History of a structural cardiac abnormality or other serious cardiac problems.
- Non-responder to psychostimulant treatment.
- Is overweight.
- Seizures during the last 2 years (exclusive of infantile febrile seizures), a tic disorder, a current diagnosis and/or family history of Tourette's Disorder.
- Has Conduct Disorder.
- Known history of alcohol or other substance abuse within the last 6 months.
- Any abnormal thyroid function.
- A concurrent chronic or acute illness, disability, or other condition that might confound results of safety assessments.
- Has had treatment with any known liver altering agents within 30 days prior to Screening.
- Taking any excluded medication.
- Previous use of DAYTRANA.
- Taking other medications that have Central Nervous System (CNS) effects.
- Female subject is pregnant or lactating.
- Has any skin disease, or history of any chronic skin disease, skin cancer, skin manifestations of allergic disease, or other dermatologic conditions.
- Has sensitive-skin syndrome or has sensitivities to the ingredients in soaps, lotions, cosmetics or adhesives.
- Has clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites.
- A documented allergy, hypersensitivity or intolerance of methylphenidate (MPH) or any components found in DAYTRANA.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT00434213
Start Date
January 1 2007
End Date
July 1 2008
Last Update
April 26 2017
Active Locations (29)
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1
Scottsdale, Arizona, United States
2
Irvine, California, United States
3
San Marcos, California, United States
4
Spring Valley, California, United States