Attention Deficit Hyperactivity DisorderPhase 4NCT00381758
The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting
A Phase 4 study testing Methylphenidate Extended Release Capsules in people with Attention Deficit Hyperactivity Disorder, run by UCB Pharma.
Trial summary
This study was designed to compare Concerta Extended Release tablets with Metadate CD capsules in children with ADHD who were between 6 and 12 years old. The effects on ADHD symptoms, and any side effects of treatment, were measured for 12 hours after dosing in a simulated classroom. 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?
- Methylphenidate Extended Release Capsules
- Type of treatment
- Pill or oral medicine
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Aug 2002
- Phase
- Phase 4
- 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
- 6 -12 years of age, inclusive
- Have a diagnosis of ADHD
- Receiving an approved form of MPH (methylphenidate) and have demonstrated clinical improvement during this treatment.
Who cannot join
- IQ below 80.
- The patient, or a first-degree relative, has a confirmed diagnosis of Tourette's syndrome or a clinically significant tic disorder.
- History of seizures (excluding uncomplicated childhood febrile seizures).
- Myocardial infarction within 3 months of study entry, or has a history of cardiac disease, congenital cardiac abnormality, glaucoma, hyperthyroidism.
- Comorbid psychiatric diagnosis.
- Exhibits extreme aggressive behavior or destruction of property, marked anxiety, tension, or agitation.
About this study
Official title: A Randomized, Double-Blind Comparison of the Time Course of Response to Two Extended-Release Oral Delivery Systems for Methylphenidate in Pediatric Patients With Attention Deficit Hyperactivity Disorder in an Analog Classroom Setting: The CoMACS Study
This study was designed to compare Concerta Extended Release tablets with Metadate CD capsules in children with ADHD who were between 6 and 12 years old. The effects on ADHD symptoms, and any side effects of treatment, were measured for 12 hours after dosing in a simulated classroom. The treatments were blinded and the effects were compared with a Placebo.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate Extended Release Capsules
- Keywords
- ADHD, Methylphenidate, Metadate CD, Concerta, COMACS, Attention Deficit Hyperactivity Disorder (ADHD)
- 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.
Methylphenidate Extended Release CapsulesDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
School Day Efficacy
SKAMP (Swanson Kotkin Agler MFlynn Pelham) ADHD Rating Scale: Deportment Items
1.5 - 7.5 hours post-dosing
Secondary outcomes (7)
SKAMP Attention Items, 1.5-12 hrs;
PERMP (Permanent Product of arithmetic) (# Problems Attempted & # Complete), 1.5-12 hrs;
SNAP IV (Swanson Nolan Pelham), day 3 & 7;
Treatment Emergent Adverse Events, once weekly;
Barkley Symptom scale, once weekly
Patient Satisfaction,once weekly
Parent Satisfaction & Treatment Preference once weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startMay 2002
- Primary completionAug 2002
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 184 participants
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Simon Hatch, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381758
- Sponsor's protocol ID
- CD00600
- Status last verified
- Mar 2008
- First submitted
- 26 Sep 2006
- Last updated
- 10 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Comparison of the Time Course of Response to Two Extended-Release Oral Delivery Systems for Methylphenidate in Pediatric Patients With Attention Deficit Hyperactivity Disorder in an Analog Classroom Setting: The CoMACS Study
- ClinicalTrials.gov ID
- NCT00381758
- Acronym / sponsor ID
- CD00600
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Methylphenidate, Metadate CD, Concerta, COMACS, Attention Deficit Hyperactivity Disorder (ADHD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002 (actual)
- First posted
- 28 Sep 2006 (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.
This study was designed to compare Concerta Extended Release tablets with Metadate CD capsules in children with ADHD who were between 6 and 12 years old. The effects on ADHD symptoms, and any side effects of treatment, were measured for 12 hours after dosing in a simulated classroom. The treatments were blinded and the effects were compared with a Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 6 -12 years of age, inclusive
- Have a diagnosis of ADHD
- Receiving an approved form of MPH (methylphenidate) and have demonstrated clinical improvement during this treatment.
Key exclusion criteria (6 listed)
- IQ below 80.
- The patient, or a first-degree relative, has a confirmed diagnosis of Tourette's syndrome or a clinically significant tic disorder.
- History of seizures (excluding uncomplicated childhood febrile seizures).
- Myocardial infarction within 3 months of study entry, or has a history of cardiac disease, congenital cardiac abnormality, glaucoma, hyperthyroidism.
- Comorbid psychiatric diagnosis.
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 |
|---|---|---|
| Methylphenidate Extended Release Capsules | Drug | – |
Primary outcome
School Day Efficacy
SKAMP (Swanson Kotkin Agler MFlynn Pelham) ADHD Rating Scale: Deportment Items
1.5 - 7.5 hours post-dosing
7 secondary outcomes
SKAMP Attention Items, 1.5-12 hrs;
PERMP (Permanent Product of arithmetic) (# Problems Attempted & # Complete), 1.5-12 hrs;
SNAP IV (Swanson Nolan Pelham), day 3 & 7;
Treatment Emergent Adverse Events, once weekly;
Barkley Symptom scale, once weekly
Patient Satisfaction,once weekly
Parent Satisfaction & Treatment Preference once weekly
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 10 Mar 2008.
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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.
Simon Hatch study director
UCB Pharma
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate Extended Release Capsules in people with Attention Deficit Hyperactivity Disorder, run by UCB Pharma.
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 3 inclusion and 6 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 10 Mar 2008. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
School Day Efficacy. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2008.