Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269815
Status:
COMPLETED
Last Update Posted:
2011-06-14
First Post:
2005-12-22
Brief Title:
Long-term Safety and Effectiveness of OROS Methylphenidate HCl in Children With Attention Deficit Hyperactivity Disorder
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
Long-term Safety and Effectiveness of OROS Methylphenidate HCl in Children With ADHD
Status:
COMPLETED
Status Verified Date:
2011-06
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:
The purpose of this study is to evaluate the long-term safety and effectiveness of OROSÂ Methylphenidate HCl a central nervous system stimulant in children with attention deficit hyperactivity disorder ADHD
Detailed Description:
Attention Deficit Hyperactivity Disorder ADHD represents the most common neurobehavioral disorder in children affecting 3 to 5 of the school-age population Behavioral pediatricians child psychiatrists and child neurologists indicate that referrals for ADHD may constitute up to 50 of their practices This is a multicenter open-label non-randomized single-treatment study in children 6 to 13 years of age with ADHD who have successfully completed specific earlier ALZA studies Part I of this study will evaluate the safety and effectiveness of OROS methylphenidate HCl for a period of one year in children with ADHD Part II of this study continues the evaluation of the safety and effectiveness of OROS methylphenidate HCl in children with ADHD who have completed one year in Part I of the study During Part I of the study patients will be assigned to treatment with OROS methylphenidate HCl 18 36 or 54 milligrams once daily as determined by the results from their participation in earlier ALZA studies Patients continuing in Part II of the study continue to receive a daily dose as determined from the dosing at the end of Part I Doses can be titrated up or down as considered appropriate by the medical personnel at the study site with a maximum once-daily dose of 54 milligrams Effectiveness is determined by standardized measurements of attention behavior and hyperactivity including the IOWA Inattention Overactivity with Aggression Conners Rating Scale InattentionOveractivity IO and OppositionalDefiance OD subscales Peer Interaction assessment Global evaluation of effectiveness of therapy and the Parent Satisfaction Questionnaire Safety evaluations include the incidence of adverse events physical examinations clinical laboratory tests vital signs sleep quality appetite and the presenceseverity of tics hard-to-control repeated twitching of any parts of the body or hard-to-control repeating of sounds or words
Data will be summarized and no formal hypotheses will be tested Part I A daily morning oral dose of 18 36 or 54 milligrams of OROS methylphenidate HCl for up to 12 months Part II Continuation for up to 15 months of the same daily dose taken at the end of Part I Total treatment duration to approximately 27 months
Data will be summarized and no formal hypotheses will be tested Part I A daily morning oral dose of 18 36 or 54 milligrams of OROS methylphenidate HCl for up to 12 months Part II Continuation for up to 15 months of the same daily dose taken at the end of Part I Total treatment duration to approximately 27 months
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