Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT00381758
Status:
COMPLETED
Last Update Posted:
2008-03-10
First Post:
2006-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-07', 'studyFirstSubmitDate': '2006-09-26', 'studyFirstSubmitQcDate': '2006-09-27', 'lastUpdatePostDateStruct': {'date': '2008-03-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'School Day Efficacy'}, {'measure': 'SKAMP (Swanson Kotkin Agler MFlynn Pelham) ADHD Rating Scale: Deportment Items'}, {'measure': '1.5 - 7.5 hours post-dosing'}], 'secondaryOutcomes': [{'measure': 'SKAMP Attention Items, 1.5-12 hrs;'}, {'measure': 'PERMP (Permanent Product of arithmetic) (# Problems Attempted & # Complete), 1.5-12 hrs;'}, {'measure': 'SNAP IV (Swanson Nolan Pelham), day 3 & 7;'}, {'measure': 'Treatment Emergent Adverse Events, once weekly;'}, {'measure': 'Barkley Symptom scale, once weekly'}, {'measure': 'Patient Satisfaction,once weekly'}, {'measure': 'Parent Satisfaction & Treatment Preference once weekly'}]}, 'conditionsModule': {'keywords': ['ADHD', 'Methylphenidate', 'Metadate CD', 'Concerta', 'COMACS', 'Attention Deficit Hyperactivity Disorder (ADHD)'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 6 -12 years of age, inclusive\n* Have a diagnosis of ADHD\n* Receiving an approved form of MPH (methylphenidate) and have demonstrated clinical improvement during this treatment.\n\nExclusion Criteria:\n\n* IQ below 80.\n* The patient, or a first-degree relative, has a confirmed diagnosis of Tourette's syndrome or a clinically significant tic disorder.\n* History of seizures (excluding uncomplicated childhood febrile seizures).\n* Myocardial infarction within 3 months of study entry, or has a history of cardiac disease, congenital cardiac abnormality, glaucoma, hyperthyroidism.\n* Comorbid psychiatric diagnosis.\n* Exhibits extreme aggressive behavior or destruction of property, marked anxiety, tension, or agitation."}, 'identificationModule': {'nctId': 'NCT00381758', 'briefTitle': 'The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CD00600'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Methylphenidate Extended Release Capsules', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Simon Hatch', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UCB Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}}}}