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The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting

NCT00381758 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2008-03-10

No results posted yet for this study

Summary

This study was designed to compare Concerta Extended Release tablets with Metadate CD capsules in children with ADHD who were between 6 and 12 years old. The effects on ADHD symptoms, and any side effects of treatment, were measured for 12 hours after dosing in a simulated classroom. The treatments were blinded and the effects were compared with a Placebo.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Methylphenidate Extended Release Capsules

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • Simon Hatch · UCB Pharma

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
2002-05-31
Primary Completion
2002-08-31
Completion
2002-08-31

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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 NCT00381758 on ClinicalTrials.gov