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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00269802
Recruitment Status : Completed
First Posted : December 26, 2005
Last Update Posted : June 10, 2011
Information provided by:
Alza Corporation, DE, USA

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: OROS methylphenidate HCl Drug: Ritalin Drug: Placebo Phase 3

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

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multicenter Study Comparing the Efficacy and Safety of OROS (Methylphenidate HCl), Ritalin, and Placebo in Children With ADHD
Actual Study Completion Date : February 1999

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 001
OROS methylphenidate HCl
Drug: OROS methylphenidate HCl
Active Comparator: 002
Drug: Ritalin
Placebo Comparator: 003
Drug: Placebo

Primary Outcome Measures :
  1. IOWA Conners Rating Scale (Inattention/Overactivity subscale) rating by the teacher on Day 27.

Secondary Outcome Measures :
  1. Teacher's IOWA Conners (Inattention/Overactivity and Oppositional Defiance subscales) rating on Days 1, 6, 13, 20, and 27; Incidence of adverse events; Changes in physical exams, laboratory tests, vital signs, sleep quality, appetite, and tics

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who have successfully completed the ALZA screening protocol C-98-011 within the past six months
  • taking or have taken in the past 5 - 20 mg of immediate-release methylphenidate (Ritalin®) at least twice a day, 20 - 60 mg of sustained-release methylphenidate (Ritalin-SR®) per day, or a combination of immediate-release and sustained-release methylphenidate up to a daily dose not exceeding 60 mg, or have successfully completed ALZA Protocol C-98-007
  • agreeing to take only the supplied study drug as treatment for ADHD during the four-week treatment phase of the study
  • who are able to comply with the study visit schedule and whose parent(s) and teacher are willing and able to complete the protocol-specified assessments
  • having normal urinalysis, hematological and blood chemistry values or, if values are outside the normal range, they are determined to be not clinically significant by the investigator

Exclusion Criteria:

  • Patients who have clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract
  • having glaucoma, an ongoing seizure disorder, a psychotic disorder, clinical depression (and are suicidal or require immediate treatment for depression), or a diagnosis of Tourette's syndrome
  • having a known allergy to methylphenidate or currently having significant adverse experiences from methylphenidate
  • having a mean of two blood pressure measurements (systolic or diastolic) equal to or greater than the 95th percentile for age, sex, and height at screening
  • if female, have begun menstruation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00269802

Sponsors and Collaborators
Alza Corporation, DE, USA
Study Director: Alza Corporation Clinical Trial ALZA

Publications of Results: Identifier: NCT00269802     History of Changes
Other Study ID Numbers: CR005995
First Posted: December 26, 2005    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by Alza Corporation, DE, USA:
Attention Deficit Hyperactivity Disorder

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents