A Multicenter Study Comparing the Efficacy and Safety of OROS Methylphenidate HCl, Ritalin (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of OROSÂ® Methylphenidate
      HCl as compared with placebo and standard immediate-release RitalinÂ® (taken three time per
      day) for the treatment of Attention Deficit Hyperactivity Disorder in children. Both OROSÂ®
      Methylphenidate HCl and RitalinÂ® 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
      (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
    

Intervention name(s): OROS methylphenidate HCl; Ritalin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ADHD; Attention Deficit Hyperactivity Disorder; OROS®; Ritalin®; children; methylphenidate