A Randomized, Double-Blind Comparison of the Time Course of Response to Two Extended-Release Oral Delivery Systems for Methylphenidate in Pediatric Patients With Attention Deficit Hyperactivity Disorder in an Analog Classroom Setting: The CoMACS Study

UCB Pharma0 个研究点目标入组 184 人开始时间: 2002年5月1日最近更新: 2008年3月10日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: UCB Pharma
入组人数: 184
主要终点: School Day Efficacy

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 6 Years 至 12 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•6 -12 years of age, inclusive
•Have a diagnosis of ADHD
•Receiving an approved form of MPH (methylphenidate) and have demonstrated clinical improvement during this treatment.

排除标准

•The patient, or a first-degree relative, has a confirmed diagnosis of Tourette's syndrome or a clinically significant tic disorder.
•History of seizures (excluding uncomplicated childhood febrile seizures).
•Myocardial infarction within 3 months of study entry, or has a history of cardiac disease, congenital cardiac abnormality, glaucoma, hyperthyroidism.
•Comorbid psychiatric diagnosis.
•Exhibits extreme aggressive behavior or destruction of property, marked anxiety, tension, or agitation.

结局指标

主要结局

School Day Efficacy

SKAMP (Swanson Kotkin Agler MFlynn Pelham) ADHD Rating Scale: Deportment Items

1.5 - 7.5 hours post-dosing

次要结局

SKAMP Attention Items, 1.5-12 hrs;
PERMP (Permanent Product of arithmetic) (# Problems Attempted & # Complete), 1.5-12 hrs;
SNAP IV (Swanson Nolan Pelham), day 3 & 7;
Treatment Emergent Adverse Events, once weekly;
Barkley Symptom scale, once weekly
Patient Satisfaction,once weekly
Parent Satisfaction & Treatment Preference once weekly

研究者

发起方

UCB Pharma

申办方类型

Industry

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