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

NCT00269802 | Completed Phase 3

• 1 other identifier: CR005995
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Attention Deficit Hyperactivity Disorder; OROS®; Ritalin®; children; methylphenidate

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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

Study Arms (3)

001

EXPERIMENTAL

OROS methylphenidate HCl

Drug: OROS methylphenidate HCl

002

ACTIVE COMPARATOR

Ritalin

Drug: Ritalin

003

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

OROS methylphenidate HCl DRUG

001

Ritalin DRUG

002

Placebo DRUG

003

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alza Corporation, DE, USA: lead

Related Publications (1)

• Wolraich ML, Greenhill LL, Pelham W, Swanson J, Wilens T, Palumbo D, Atkins M, McBurnett K, Bukstein O, August G. Randomized, controlled trial of oros methylphenidate once a day in children with attention-deficit/hyperactivity disorder. Pediatrics. 2001 Oct;108(4):883-92. doi: 10.1542/peds.108.4.883.

  PMID: 11581440 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Alza Corporation Clinical Trial

  ALZA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Completion: February 1, 1999
• Last Updated: June 10, 2011

Record last verified: 2011-06