NCT00269776

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 improving attention and behavior, and decreasing hyperactivity in children with Attention Deficit Hyperactivity Disorder (ADHD). Both OROS Methylphenidate HCl and Ritalin contain the central nervous system stimulant, methylphenidate HCl. The safety associated with the two methylphenidate formulations will also be compared with placebo.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 1998

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1999

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 26, 2005

Completed
Last Updated

July 11, 2011

Status Verified

July 1, 2011

First QC Date

December 22, 2005

Last Update Submit

July 8, 2011

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHDAttention Deficit Hyperactivity DisorderOROSchildrenmethylphenidateRitalin

Outcome Measures

Primary Outcomes (1)

  • IOWA Conners Inattention/Overactivity subscale ratings by the Community School Teacher

    Up to Day 6 of each treatment period for a total of approximatly 18 days

Secondary Outcomes (5)

  • SKAMP attention and deportment ratings

    Up to Day 7 of each of 3 treatment periods for a total of approximately 21 days

  • Peer interaction ratings

    Up to Day 7 of each of 3 treatment periods for a total of approximately 21 days

  • Laboratory School Teacher Global Assessments

    Up to Day 7 of each of 3 treatment periods for a total of approximately 21 days

  • SNAP-IV ratings

    Up to Day 7 of each of 3 treatment periods for a total of approximately 21 days

  • Incidence of adverse events

    Up to Day 7 of each of 3 treatment periods for a total of approximately 21 days

Study Arms (3)

001

EXPERIMENTAL

OROS (methylphenidate HCl) Treatment A: 1 2 or 3 OROS methylphenidate 18-mg tablets + 0 1 or 2 OROS placebo tablets (3 tablets in total) once daily + 1 placebo capsule 3x/day for 7 days. Each patient will be randomized to 1 of 9 treatment sequences each consisting of 3 7-day treatment periods of Treatment A B and C.

Drug: OROS (methylphenidate HCl)

002

EXPERIMENTAL

Ritalin (methylphenidate) Treatment B: 5 10 or 15-mg tablets (encapsulated/single capsule) 3 times a day + 3 OROS placebo tablets once daily for 7 days. Each patient will be randomized to 1 of 9 treatment sequences each consisting of 3 7-day treatment periods of Treatment A B and C.

Drug: Ritalin (methylphenidate)

003

EXPERIMENTAL

Placebo Treatment C: Three OROS placebo tablets once daily + 1 placebo capsule 3x times/day for 7 days. Each patient will be randomized to 1 of 9 treatment sequences each consisting of 3 7-day treatment periods of Treatment A B and C.

Drug: Placebo

Interventions

PlaceboDRUG

Treatment C: Three OROS placebo tablets once daily + 1 placebo capsule 3x times/day for 7 days. Each patient will be randomized to 1 of 9 treatment sequences each consisting of 3 7-day treatment periods of Treatment A, B, and C.

003
OROS (methylphenidate HCl)DRUG

Treatment A: 1, 2, or 3 OROS methylphenidate 18-mg tablets + 0, 1, or 2 OROS placebo tablets (3 tablets in total) once daily + 1 placebo capsule 3x/day for 7 days. Each patient will be randomized to 1 of 9 treatment sequences each consisting of 3 7-day treatment periods of Treatment A, B, and C.

001
Ritalin (methylphenidate)DRUG

Treatment B: 5, 10, or 15-mg tablets (encapsulated/single capsule) 3 times a day + 3 OROS placebo tablets once daily for 7 days. Each patient will be randomized to 1 of 9 treatment sequences each consisting of 3 7-day treatment periods of Treatment A, B, and C.

002

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Swanson J, Gupta S, Lam A, Shoulson I, Lerner M, Modi N, Lindemulder E, Wigal S. Development of a new once-a-day formulation of methylphenidate for the treatment of attention-deficit/hyperactivity disorder: proof-of-concept and proof-of-product studies. Arch Gen Psychiatry. 2003 Feb;60(2):204-11. doi: 10.1001/archpsyc.60.2.204.

    PMID: 12578439RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Alza Corporation Clinical Trial

    ALZA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 26, 2005

Study Start

November 1, 1998

Study Completion

January 1, 1999

Last Updated

July 11, 2011

Record last verified: 2011-07