Trials / Completed
CompletedNCT00381758
The COMACS Study: A Comparison of Methylphenidates in an Analog Classroom Setting
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 184 (planned)
- Sponsor
- UCB Pharma · Industry
- Sex
- All
- Age
- 6 Years – 12 Years
- Healthy volunteers
- Not accepted
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. The treatments were blinded and the effects were compared with a Placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Methylphenidate Extended Release Capsules |
Timeline
- Start date
- 2002-05-01
- Primary completion
- 2002-08-01
- Completion
- 2002-08-01
- First posted
- 2006-09-28
- Last updated
- 2008-03-10
Source: ClinicalTrials.gov record NCT00381758. Inclusion in this directory is not an endorsement.