A Multicenter Study Comparing the Efficacy and Safety of OROS Methylphenidate HCl, Ritalin (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title: Multicenter Study Comparing the Efficacy and Safety of OROS (Methylphenidate HCl), Ritalin, and Placebo in Children With ADHD

Status Completed

Clinical Trial 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.

Clinical Trial 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 (encapsulated/single 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 teacher's rating on study Day 27 on the IOWA Conners Inattention/Overactivity subscale. Additional measures of effectiveness include the IOWA Conners Oppositional/Defiance 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 presence/severity 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 (encapsulated/single capsule) three times daily, or placebo ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

• NCT number: NCT00269802
• Study type: Interventional
• Source: Alza Corporation, DE, USA
• Status: Completed
• Phase: Phase 3
• Completion date: February 1999