Long-term Safety and Effectiveness of OROS Methylphenidate HCl in Children With Attention Deficit Hyperactivity Disorder

NCT00269815 | Completed Phase 3

• 1 other identifier: CR006001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the long-term safety and effectiveness of OROS® Methylphenidate HCl (a central nervous system stimulant) in children with attention deficit hyperactivity disorder (ADHD).

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Attention Deficit Hyperactivity Disorder; OROS®; children; methylphenidate

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events; Changes in physical examinations, clinical laboratory tests, vital signs, sleep quality, appetite, and tics

Secondary Outcomes (1)

• IOWA (Inattention Overactivity with Aggression) Conners Rating Scale, Inattention/Overactivity (I/O) and Oppositional/Defiance (O/D) subscales; Peer Interaction assessment; Global evaluation of effectiveness of therapy; Parent Satisfaction Questionnaire

Study Arms (1)

001

EXPERIMENTAL

methylphenidate HCl

Drug: methylphenidate HCl

Interventions

methylphenidate HCl DRUG

001

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients who have successfully completed one of the following earlier ALZA studies: CR005992, C-97-033 (and then successfully completed C-98-011), CR005989, or CR005995, without significant drug-related adverse events
• whose primary care physician agrees that it is appropriate to participate in this study
• who agree to take only the OROS® (methylphenidate HCl) supplied and no other methylphenidate dosage form or other medications for the treatment of ADHD during the study
• who are able to comply with the study visit schedule and whose parent(s) and teachers are willing and able to complete the protocol-specified assessments
• who have normal urinalysis, hematological and blood chemistry values or, if values are outside the normal range, they are determined not clinically significant by the investigator

You may not qualify if:

• Patients having clinically significant gastrointestinal problems, including narrowing of the gastrointestinal tract
• having any coexisting medical condition or are taking any medication that is likely to interfere with safe administration of methylphenidate
• having a known hypersensitivity to methylphenidate
• having a history of high blood pressure or who have a blood pressure (systolic or diastolic) equal to or greater than the 95th percentile for age, gender and height
• if female, have begun menstruation

Sponsors & Collaborators

• Alza Corporation, DE, USA: lead

Related Publications (1)

• Wilens T, McBurnett K, Stein M, Lerner M, Spencer T, Wolraich M. ADHD treatment with once-daily OROS methylphenidate: final results from a long-term open-label study. J Am Acad Child Adolesc Psychiatry. 2005 Oct;44(10):1015-23. doi: 10.1097/01.chi.0000173291.28688.e7.

  PMID: 16175106 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Alza Corporation Clinical Trial

  ALZA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Completion: December 1, 1999
• Last Updated: June 14, 2011

Record last verified: 2011-06