A Comparative Effectiveness Study Evaluating OROS Methylphenidate HCl, Ritalin (Methylphenidate HCl), and Placebo for the Treatment of Attention Deficit Hyperactivity Disorder in Children

This study has been completed.
Sponsor:
Information provided by:
Alza Corporation, DE, USA
ClinicalTrials.gov Identifier:
NCT00269789
First received: December 22, 2005
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

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.


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

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • IOWA Conners Inattention/Overactivity subscale ratings by the Community School Teacher on Days 6, 13 and 20, evaluating study days 2 - 6, 9 - 13, and 16 - 20, respectively.

Secondary Outcome Measures:
  • IOWA Conners Inattention/Overactivity and Oppositional/Defiance subscale ratings; SKAMP attention and deportment ratings; Global assessments; Accuracy and completion on assigned academic tasks; Peer interactions ratings; Incidence of adverse events

Study Start Date: March 1998
Study Completion Date: May 1998
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. 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 parents/caregivers, community school teachers, laboratory school teachers and the laboratory school counselor. The primary measure of effectiveness is the community school teacher's rating on the IOWA Conners Inattention/Overactivity subscale. Additional measures of effectiveness include IOWA Conners (Inattention/Overactivity and Oppositional/Defiance 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 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 oral doses of: OROS® (methylphenidate HCl) either 1, 2 or 3 of the 18 milligram tablets once daily, Ritalin® 5, 10, or 15 mg (encapsulated/single 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.

  Eligibility

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

Inclusion Criteria:

  • Patients with a diagnosis of one of the three subtypes of Attention Deficit Hyperactivity Disorder (ADHD) verified by both a parent/child interview and a teacher assessment using SNAP-IV questionnaires
  • taking 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
  • having used methylphenidate for at least 3 months at some time in the past and have been on the same dose for the previous 4-week period without any significant adverse experiences, considered to be positive responders to methylphenidate therapy, and agreeing to take only the supplied study drug as treatment for ADHD during the three-week treatment phase of the study
  • able to comply with the study visit schedule and whose parent(s) and teacher are willing and able to complete the protocol-specified assessments, including behavior modification procedures
  • agreeing not to ingest any caffeine containing beverages (e.g., coffee or soda) or foods (e.g., chocolate) on days 7, 14, and 21 of the study

Exclusion Criteria:

  • Patients having clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract
  • considered markedly anxious, tense, agitated, or depressed, having psychotic disorders, a history of seizures, or having a diagnosis of Tourette's syndrome
  • whose primary treatment focus is oppositional-defiant disorder, conduct disorder, or tics, or whose primary treatment focus is other psychiatric conditions such as depressive disorders, bipolar disorders, or other mood disorders
  • having a mean of two blood pressure measurements (systolic or diastolic) equal to or greater than the 95th percentile for age, sex, and height
  • if female, have begun menstruation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269789

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

Publications:
ClinicalTrials.gov Identifier: NCT00269789     History of Changes
Other Study ID Numbers: CR005992
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:
Attention Deficit Hyperactivity Disorder
OROS®
Ritalin®
children
methylphenidate
ADHD

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

ClinicalTrials.gov processed this record on September 15, 2014