Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518232
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2007-08-16
Brief Title:
A Study to Determine Effective and Tolerable Titration Scheme for OROS-Methylphenidate in Children With Attention-deficit Hyperactivity Disorder
Sponsor:
Johnson Johnson Taiwan Ltd
Organization:
Johnson Johnson Taiwan Ltd
Study Overview
Official Title:
The Effective and Tolerable Titration Scheme and Dosage in Children With Attention-deficit Hyperactivity Disorder Treated With OROS-Methylphenidate
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to investigate the clinical benefit of switching children with ADHD from immediate-release methylphenidate IR-MPH to OROS-methylphenidate under the correct dosage conversion scheme
Detailed Description:
This is a prospective non-comparative study Each patient will be treated for 10 weeks including 6-week titration phase and 4-week maintenance phase After an initial baseline evaluation patients currently receiving IR-Methylphenidate IR-MPH therapy will switch to receiving OROS-methylphenidate once daily Patients receiving IR-MPH 15 mg per day will switch to receive 18 mg once daily OROS-methylphenidate For patients on IR-MPH daily dosage 15 mg and 30 mg the initial dose of OROS-methylphenidate will be 36 mg once daily Other patients receiving IR-MPH higher than 30 mg per day will switch to receive 54 mg once daily OROS-methylphenidate During the 6-week titration phase those patients who do not achieve the criteria of Optimal Response will be titrated by biweekly increase to next dose level 36 mg per day and then 54 mg per day The maximum dose of OROS-methylphenidate per day is 54 mg as package insert indicates However dose decreases are allowed if clinically intolerable adverse events emerge At the end of 6-week titration phase the final titration dose should be maintained for the last 4 weeks of the trial regardless of the optimal response In summary all patients will attend bi-weekly clinic visits for the first 6 weeks visit 2 to 4 and monthly clinic visits for the subsequent 4 weeks visit 5 Patients will receive 18 mg or 36mg or 54 mg once daily OROS-methylphenidate for 10 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None