The COMACS Study: A Comparison of Methylphenidates in an... | NCT00381758

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

NCT00381758

Sponsor

UCB Pharma

Status

Completed

Last Update Posted

Mar 10, 2008Estimated

Enrollment

184

Phase

Phase 4

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Methylphenidate Extended Release Capsules

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Aug 2002Actual

Completion Date

Aug 2002Actual

First Submitted Date

Sep 26, 2006

First Submission Date that Met QC Criteria

Sep 27, 2006

First Posted Date

Sep 28, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2008

Last Update Posted Date

Mar 10, 2008Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

184

Name	Type	Description	Arm Group Labels	Other Names
Methylphenidate Extended Release Capsules	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
School Day Efficacy
SKAMP (Swanson Kotkin Agler MFlynn Pelham) ADHD Rating Scale: Deportment Items
1.5 - 7.5 hours post-dosing

Secondary Outcomes

Measure	Description	Time Frame
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;

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

IQ below 80.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Simon Hatch	UCB Pharma	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided