An Effectiveness and Safety Study Evaluating OROS Methylphenidate Hydrochloride (HCl), Ritalin (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder
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ClinicalTrials.gov Identifier: NCT00269776 |
Recruitment Status
:
Completed
First Posted
: December 26, 2005
Last Update Posted
: July 11, 2011
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Condition or disease | Intervention/treatment | Phase |
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Attention Deficit Hyperactivity Disorder | Drug: Placebo Drug: OROS (methylphenidate HCl) Drug: Ritalin (methylphenidate) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Screening, Efficacy, and Safety Study Evaluating OROS (Methylphenidate HCl), Ritalin and Placebo in Children With ADHD |
Study Start Date : | November 1998 |
Actual Study Completion Date : | January 1999 |

Arm | Intervention/treatment |
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Experimental: 001
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.
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Drug: 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.
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Experimental: 002
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.
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Drug: 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.
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Experimental: 003
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.
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Drug: 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.
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- IOWA Conners Inattention/Overactivity subscale ratings by the Community School Teacher [ Time Frame: Up to Day 6 of each treatment period for a total of approximatly 18 days ]
- SKAMP attention and deportment ratings [ Time Frame: Up to Day 7 of each of 3 treatment periods for a total of approximately 21 days ]
- Peer interaction ratings [ Time Frame: Up to Day 7 of each of 3 treatment periods for a total of approximately 21 days ]
- Laboratory School Teacher Global Assessments [ Time Frame: Up to Day 7 of each of 3 treatment periods for a total of approximately 21 days ]
- SNAP-IV ratings [ Time Frame: Up to Day 7 of each of 3 treatment periods for a total of approximately 21 days ]
- Incidence of adverse events [ Time Frame: Up to Day 7 of each of 3 treatment periods for a total of approximately 21 days ]

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Ages Eligible for Study: | 6 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269776
Study Director: | Alza Corporation Clinical Trial | ALZA |
Publications of Results:
Responsible Party: | Director, Clinical Research - CNS, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00269776 History of Changes |
Other Study ID Numbers: |
CR005989 CONCERTAATT3019 C-98-003-02 |
First Posted: | December 26, 2005 Key Record Dates |
Last Update Posted: | July 11, 2011 |
Last Verified: | July 2011 |
Keywords provided by Alza Corporation, DE, USA:
ADHD Attention Deficit Hyperactivity Disorder OROS |
children methylphenidate Ritalin |
Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Methylphenidate Central Nervous System Stimulants Physiological Effects of Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents |