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

This study has been completed.
Sponsor:
Information provided by:
Alza Corporation, DE, USA
ClinicalTrials.gov Identifier:
NCT00269802
First received: December 22, 2005
Last updated: June 9, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Attention Deficit Hyperactivity Disorder
 Drug: OROS methylphenidate HCl
Drug: Ritalin
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multicenter Study Comparing the Efficacy and Safety of OROS (Methylphenidate HCl), Ritalin, and Placebo in Children With ADHD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alza Corporation, DE, USA:

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

Secondary Outcome Measures:
  • 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

Study Completion Date: February 1999
Arms Assigned Interventions
Experimental: 001
OROS methylphenidate HCl
 Drug: OROS methylphenidate HCl
Active Comparator: 002
Ritalin
 Drug: Ritalin
Placebo Comparator: 003
Placebo
 Drug: Placebo

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

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269802

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

Publications:

ClinicalTrials.gov Identifier: NCT00269802     History of Changes
Other Study ID Numbers: CR005995
Study First Received: December 22, 2005
Last Updated: June 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Alza Corporation, DE, USA:
ADHD
Attention Deficit Hyperactivity Disorder
OROS®
 Ritalin®
children
methylphenidate

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
 Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013