Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269789
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-12-22
Brief Title:
A Comparative Effectiveness Study Evaluating OROS Methylphenidate HCl Ritalin Methylphenidate HCl and Placebo for the Treatment of Attention Deficit Hyperactivity Disorder in Children
Sponsor:
Alza Corporation DE USA
Organization:
Alza Corporation DE USA
Study Overview
Official Title:
Comparative Crossover Study 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 compare the effectiveness onset of effect time to loss of effect and overall efficacy of methylphenidate given as an OROS methylphenidate HCl formulation compared to immediate-release Ritalin and placebo for the treatment of Attention Deficit Hyperactivity Disorder ADHD in children using standardized attention and behavior scales and other assessments 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 This is a double-blind double-dummy randomized placebo-controlled active-controlled crossover trial in children with ADHD to compare the safety and effectiveness onset of effect time to loss of effect and overall efficacy of OROS Methylphenidate HCl with standard immediate-release Ritalin and placebo During this study patients receive each of the three treatments OROS Methylphenidate HCl 18 36 or 54 milligrams per day Ritalin 5 10 or 15 milligrams three times per day or placebo for 7 days and are assigned to one of three dosage levels depending upon their prestudy methylphenidate dose and regimen The total study participation for each patient will be 21 days Since ADHD is manifested in a variety of settings and can affect attention and behavior this study assesses efficacy in home community school and laboratory school settings using numerous assessments designed to evaluate various aspects of the disorder These assessments are completed by a variety of raters including the parentscaregivers community school teachers laboratory school teachers and the laboratory school counselor The primary measure of effectiveness is the community school teachers rating on the IOWA Conners InattentionOveractivity subscale Additional measures of effectiveness include IOWA Conners InattentionOveractivity and OppositionalDefiance subscale ratings SKAMP attention and deportment ratings peer interaction and other behavioral ratings global assessments accuracy and productivity of independent assigned academic seatwork and assessments of positive and negative social behaviors classroom rule violations and disruptive behaviors Safety evaluations include the incidence of adverse events 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 oral doses of OROS methylphenidate HCl either 1 2 or 3 of the 18 milligram tablets once daily Ritalin 5 10 or 15 mg encapsulatedsingle capsule three times per day or placebo There are three treatment groups each group dosing for 7 days for a total of 21 days on study
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