Attention Deficit Hyperactivity DisorderPhase 3NCT00269776
An Effectiveness and Safety Study Evaluating OROS Methylphenidate Hydrochloride (HCl), Ritalin (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder
A Phase 3 study testing OROS (methylphenidate HCl) and Ritalin (methylphenidate) in people with Attention Deficit Hyperactivity Disorder, run by Alza Corporation, DE, USA.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- OROS (methylphenidate HCl) and Ritalin (methylphenidate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Nov 1998to Jan 1999
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Screening, Efficacy, and Safety Study Evaluating OROS (Methylphenidate HCl), Ritalin and Placebo in Children With ADHD
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.
Read the 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 psychiatrists, and child neurologists indicate that referrals for ADHD may constitute up to 50% of their practices. This is a double-blind, double-dummy, randomized, placebo-controlled, active-controlled, 3-treatment, 3-period crossover trial to compare the safety and effectiveness (onset of effect, time to loss of effect and overall efficacy) of OROS Methylphenidate Hydrochloride (HCl), with standard immediate-release Ritalin and placebo. During this study, patients receive each of the three treatments (OROS Methylphenidate HCl 18, 36 or 54 milligrams per day, Ritalin 5, 10 or 15 milligrams three times per day, or placebo) for 7 days, and are assigned to one of three dosage levels depending upon their prestudy methylphenidate dose and regimen. The total study participation for each patient will be 21 days. Since ADHD is manifested in a variety of settings and can affect attention and behavior, this study assesses efficacy in home, community school, and laboratory school settings using numerous assessments designed to evaluate various aspects of the disorder. These assessments are completed by a variety of raters, including the parents/caregivers, community school teachers, and laboratory school teachers. The primary measure of effectiveness is the community school teacher's rating on the IOWA Conners Inattention/Overactivity subscale. Additional measures of effectiveness include the IOWA Conners (Inattention/Overactivity and Oppositional/Defiance subscale) ratings, SKAMP attention and deportment ratings, peer interaction and other behavioral ratings, global assessments, SNAP-IV ratings, activity levels during structured activities, accuracy and productivity of independent assigned academic seatwork, and a home situation questionnaire. Safety evaluations include the incidence of adverse events, physical examinations, clinical laboratory tests, vital signs, sleep quality, actigraphy (sleep latency, duration, and arousals), appetite, and the presence/severity of tics (hard-to-control, repeated twitching of any parts of the body or hard-to-control repeating of sounds or words). Patients will be given oral doses of: OROS (methylphenidate HCl) 1, 2, or 3 of the 18-milligram tablets once daily, or Ritalin 5, 10, or 15 mg (encapsulated/single capsule) three times a day, or placebo. There are three treatment groups, each group dosing for 7 days for a total of 21 days on study.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Placebo, OROS (methylphenidate HCl), Ritalin (methylphenidate)
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder, OROS, children, methylphenidate, Ritalin
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOWA Conners Inattention/Overactivity subscale ratings by the Community School Teacher
Measured: Up to Day 6 of each treatment period for a total of approximatly 18 days
Secondary outcomes (5)
SKAMP attention and deportment ratings
Measured: Up to Day 7 of each of 3 treatment periods for a total of approximately 21 days
Peer interaction ratings
Measured: Up to Day 7 of each of 3 treatment periods for a total of approximately 21 days
Laboratory School Teacher Global Assessments
Measured: Up to Day 7 of each of 3 treatment periods for a total of approximately 21 days
SNAP-IV ratings
Measured: Up to Day 7 of each of 3 treatment periods for a total of approximately 21 days
Incidence of adverse events
Measured: Up to Day 7 of each of 3 treatment periods for a total of approximately 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2005 (estimated)
- Study startNov 1998
- Study completionJan 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
Sponsor and investigators
- Lead sponsor
- Alza Corporation, DE, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alza Corporation Clinical Trial, Study director, ALZA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269776
- Sponsor's protocol ID
- CR005989
- Other IDs
- CONCERTAATT3019, C-98-003-02
- Status last verified
- Jul 2011
- First submitted
- 22 Dec 2005
- Last updated
- 11 Jul 2011
- Results posted
- No
Publications
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.
PubMed 12578439
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening, Efficacy, and Safety Study Evaluating OROS (Methylphenidate HCl), Ritalin and Placebo in Children With ADHD
- ClinicalTrials.gov ID
- NCT00269776
- Acronym / sponsor ID
- CR005989
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder, OROS, children, methylphenidate, Ritalin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Alza Corporation, DE, USAIndustry (pharma, biotech, devices)
- Study start
- Nov 1998
- Study completion
- Jan 1999 (actual)
- First posted
- 26 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 psychiatrists, and child neurologists indicate that referrals for ADHD may constitute up to 50% of their practices. This is a double-blind, double-dummy, randomized, placebo-controlled, active-controlled, 3-treatment, 3-period crossover trial to compare the safety and effectiveness (onset of effect, time to loss of effect and overall efficacy) of OROS Methylphenidate Hydrochloride (HCl), with standard immediate-release Ritalin and placebo. During this study, patients receive each of the three treatments (OROS Methylphenidate HCl 18, 36 or 54 milligrams per day, Ritalin 5, 10 or 15 milligrams three times per day, or placebo) for 7 days, and are assigned to one of three dosage levels depending upon their prestudy methylphenidate dose and regimen. The total study participation for each patient will be 21 days. Since ADHD is manifested in a variety of settings and can affect attention and behavior, this study assesses efficacy in home, community school, and laboratory school settings using numerous assessments designed to evaluate various aspects of the disorder. These assessments are completed by a variety of raters, including the parents/caregivers, community school teachers, and laboratory school teachers. The primary measure of effectiveness is the community school teacher's rating on the IOWA Conners Inattention/Overactivity subscale. Additional measures of effectiveness include the IOWA Conners (Inattention/Overactivity and Oppositional/Defiance subscale) ratings, SKAMP attention and deportment ratings, peer interaction and other behavioral ratings, global assessments, SNAP-IV ratings, activity levels during structured activities, accuracy and productivity of independent assigned academic seatwork, and a home situation questionnaire. Safety evaluations include the incidence of adverse events, physical examinations, clinical laboratory tests, vital signs, sleep quality, actigraphy (sleep latency, duration, and arousals), appetite, and the presence/severity of tics (hard-to-control, repeated twitching of any parts of the body or hard-to-control repeating of sounds or words). Patients will be given oral doses of: OROS (methylphenidate HCl) 1, 2, or 3 of the 18-milligram tablets once daily, or Ritalin 5, 10, or 15 mg (encapsulated/single capsule) three times a day, or placebo. There are three treatment groups, each group dosing for 7 days for a total of 21 days on study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: OROS (methylphenidate HCl)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. |
| 002 | Experimental | Drug: Ritalin (methylphenidate)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. |
| 003 | Experimental | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboTreatment 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 | 003 |
| 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 | 001 |
| 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 | 002 |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2011.
- Results publication: PubMed 12578439Swanson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alza Corporation Clinical Trial study director
ALZA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OROS (methylphenidate HCl) and Ritalin (methylphenidate) in people with Attention Deficit Hyperactivity Disorder, run by Alza Corporation, DE, USA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00269776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2011.