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

NCT00269789 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2011-06-10

No results posted yet for this study

Summary

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.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Ritalin

DRUG

OROS Methylphenidate HCl

DRUG

Placebo

Sponsors & Collaborators

  • Alza Corporation, DE, USA

    lead INDUSTRY

Principal Investigators

  • Alza Corporation Clinical Trial · ALZA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-03-31
Completion
1998-05-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00269789 on ClinicalTrials.gov