Status:
COMPLETED
An Effectiveness and Safety Study Evaluating OROS Methylphenidate Hydrochloride (HCl), Ritalin (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to provide data on the effectiveness of the OROS Methylphenidate Hydrochloride (HCl) formulation compared to placebo and standard immediate-release Ritalin with respect to...
Detailed Description
Attention Deficit Hyperactivity Disorder (ADHD) represents the most common neurobehavioral disorder in children, affecting 3% to 5% of the school-age population. Behavioral pediatricians, child psychi...
Eligibility Criteria
Inclusion
- Patients having a diagnosis of one of the three subtypes of Attention Deficit Hyperactivity Disorder (ADHD) verified by both a parent/child interview and a teacher assessment using SNAP-IV questionnaires
- taking or have taken in the past 5 - 20 mg of immediate-release methylphenidate (Ritalin) at least twice a day, 20 - 60 mg of sustained-release methylphenidate (Ritalin-SR) per day, or a combination of immediate-release and sustained-release methylphenidate up to a daily dose not exceeding 60 mg
- having used methylphenidate for at least 3 months at some time in the past without any significant adverse experiences, considered to be positive responders to methylphenidate therapy, and agreeing to take to take only the supplied study drug as treatment for ADHD during the three-week treatment phase of the study
- able to comply with the study visit schedule and whose parent(s) and teacher are willing and able to complete the protocol-specified assessments
- agreeing not to ingest any caffeine containing beverages (e.g., coffee or soda) or foods (e.g., chocolate) on days 7, 14, and 21 of the study.
Exclusion
- Patients having clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract
- having glaucoma, an ongoing seizure disorder, a psychotic disorder, or have a diagnosis of Tourette's syndrome
- whose primary treatment focus is oppositional-defiant disorder, conduct disorder, or tics, or whose primary treatment focus is psychiatric conditions such as depressive disorders, bipolar disorders, or other mood disorders
- having a mean of two blood pressure measurements (systolic or diastolic) equal to or greater than the 95th percentile for age, sex, and height at screening
- if female, have begun menstruation.
Key Trial Info
Start Date :
November 1 1998
Trial Type :
INTERVENTIONAL
End Date :
January 1 1999
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00269776
Start Date
November 1 1998
End Date
January 1 1999
Last Update
July 11 2011
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