Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269802
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-12-22
Brief Title:
A Multicenter Study Comparing the Efficacy and Safety of OROS Methylphenidate HCl Ritalin Methylphenidate HCl and Placebo in Children With Attention Deficit Hyperactivity Disorder
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
Multicenter Study Comparing the Efficacy and Safety of OROS Methylphenidate HCl Ritalin and Placebo 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 efficacy and safety of OROS Methylphenidate HCl as compared with placebo and standard immediate-release Ritalin taken three time per day for the treatment of Attention Deficit Hyperactivity Disorder in children Both OROS Methylphenidate HCl and Ritalin contain the central nervous system stimulant methylphenidate HCl
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 double-blind double-dummy randomized placebo-controlled active-controlled three-treatment parallel group study to evaluate the efficacy and safety of OROS methylphenidate HCl with standard immediate-release Ritalin three times a day and placebo in children with ADHD Patients are assigned to one of three treatments depending upon their prestudy titrated therapeutic dose and regimen and are treated for 28 days Patients will be given OROS methylphenidate HCl 18 36 or 54 milligrams once daily or Ritalin 5 10 or 15 milligrams encapsulatedsingle capsule three times a day or placebo Efficacy is evaluated in the community setting by teachers parents and investigators using standardized attention and behavior scales and other assessments The primary measure of effectiveness is the teachers rating on study Day 27 on the IOWA Conners InattentionOveractivity subscale Additional measures of effectiveness include the IOWA Conners OppositionalDefiance subscale ratings peer interaction and other behavioral ratings SNAP-IV ratings global assessments of efficacy investigator Clinical Global Impression CGI home situation 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 Patients will be given orally for 28 days OROS methylphenidate HCl 1 2 or 3 of the 18 milligram tablets once daily or Ritalin 5 10 or 15 milligrams encapsulatedsingle capsule three times daily or placebo
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