Status:
COMPLETED
An Effectiveness and Safety Study of CONCERTA* vs. Immediate Release Methylphenidate (IR MPH) in Attention Deficit Hyperactivity Disorder Children
Lead Sponsor:
Janssen-Ortho Inc., Canada
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the effectiveness and safety of OROS\*methylphenidate/CONCERTA\* vs. immediate release methylphenidate as a treatment for ADHD specifically for those children...
Detailed Description
Methylphenidate, namely immediate release methylphenidate is the primary stimulant used in the treatment of children with Attention Deficit Hyperactivity Disorder (ADHD). Immediate release methylpheni...
Eligibility Criteria
Inclusion
- Patients must be between 6 and 12 years of age inclusive, have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the DSM-IV established through clinical interview by the investigator and corroborated by the SNAP-IV parent rating scale, who in the opinion of the parents/caregivers exhibit significant after-school/evening behavioural difficulties where 12 hour coverage is desired
- Eligible patients will be evaluated after a minimum 3 day washout period without ADHD medication
- In addition, patients must also have a CGI-Severity score, at baseline of "moderate", "marked", "severe" or "extremely severe" in order to be eligible
- Patients could have had no prior treatment for ADHD or are presently taking something or could have had ADHD medication treatment in the past
Exclusion
- No patients with marked anxiety, tension, aggression or agitation, glaucoma, an ongoing seizure disorder, a psychotic disorder, a diagnosis of Tourette's disorder, or a family history of Tourette's disorder, bipolar disorder, suspected mental retardation, significant learning disability, eating disorder or history of one, pre-existing gastrointestinal narrowing
- No patient with inability to swallow the medication whole, those with any unstable medical illness were excluded
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00304681
End Date
February 1 2004
Last Update
May 17 2011
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