Back to resultsPlacebo-Controlled Comparison of Two Different Brands of Modified-Release Oral Dosage Forms Regarding Safety and Efficacy in Children With Attention Deficit Hyperactivity Disorder (ADHD) Aged 6 - 14
Primary Purpose
ADHD
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Methylphenidate hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for ADHD focused on measuring ADHD, Methylphenidate hydrochloride, modified-release
Eligibility Criteria
Inclusion Criteria: Patients who meet all of the following inclusion criteria will be eligible for enrollment in the study: Male and female patients aged 6-14. Patients having a diagnosis of ADHD of any type according to DSM-IV criteria, as established by history, psychiatric examination and a structured diagnostic interview (Kiddie-Sads-Present and Lifetime Version) Patients, whose symptoms are adequately controlled by a stable and well-tolerated dose of a immediate release methylphenidate equivalent of 20mg for one month before screening. Exclusion Criteria: Patients with comorbid psychiatric conditions with symptoms requiring current pharmacological treatment (e.g. major depression, psychosis). Patients who are taking any concomitant medications likely to interfere with the study drug or confound efficacy or safety assessments, e.g. Tricyclic antidepressants, buproprion, clonidine, buspirone 2 weeks before randomization. Atomoxetine 2 weeks before randomization. Fluoxetine or antipsychotics 1 month before randomization. Pemoline and amphetamines 1 week before randomization. Patients with a known non-response to methylphenidate. Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Novartis Investigational Site
Outcomes
Primary Outcome Measures
Attention and deportment measured at 1.5, 3.0 and 4.5 hours after drug intake
Secondary Outcome Measures
7 week's treatment with two different brands of modified-release oral dosage forms of methylphenidate-HCl on attention, deportment, behavior and math in children with attention deficit hyperactivity disorder (ADHD) aged 6 - 14
Safety of 7 week's treatment with two different brands of modified-release oral dosage forms of methylphenidate-HCl
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00254878
Brief Title
Placebo-Controlled Comparison of Two Different Brands of Modified-Release Oral Dosage Forms Regarding Safety and Efficacy in Children With Attention Deficit Hyperactivity Disorder (ADHD) Aged 6 - 14
Official Title
A 7 Week Multicenter, Double-Blind, Randomized, Placebo-Controlled Cross-Over Evaluation of the Efficacy and Safety of Two Different Brands of Modified-Release Oral Dosage Forms of Methylphenidate-HCl (20 mg, q.d.) in Children With Attention Deficit Hyperactivity Disorder (ADHD) Aged 6 - 14
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
Currently two different brands of modified-release formulations are providing 50% immediate release beads/pellets and 50% extended release beads/pellets, resulting in a rapid onset and dual peak concentrations of plasma methylphenidate. One is manufactured by Novartis, the other one by Medice (Germany).
The objective of the study is to test the hypothesis that the Novartis product is superior to placebo and is clinically not inferior to the formulation manufactured by Medice.
Detailed Description
Currently two different brands of modified-release formulations are providing 50% immediate release beads/pellets and 50% extended release beads/pellets, resulting in a rapid onset and dual peak concentrations of plasma methylphenidate. One is manufactured by Novartis, the other one by Medice (Germany).
The objective of the study is to test the hypothesis that the Novartis product is superior to placebo and is clinically not inferior to the formulation manufactured by Medice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, Methylphenidate hydrochloride, modified-release
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
130 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Methylphenidate hydrochloride
Primary Outcome Measure Information:
Title
Attention and deportment measured at 1.5, 3.0 and 4.5 hours after drug intake
Secondary Outcome Measure Information:
Title
7 week's treatment with two different brands of modified-release oral dosage forms of methylphenidate-HCl on attention, deportment, behavior and math in children with attention deficit hyperactivity disorder (ADHD) aged 6 - 14
Title
Safety of 7 week's treatment with two different brands of modified-release oral dosage forms of methylphenidate-HCl
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Eligibility Criteria
Inclusion Criteria:
Patients who meet all of the following inclusion criteria will be eligible for enrollment in the study:
Male and female patients aged 6-14.
Patients having a diagnosis of ADHD of any type according to DSM-IV criteria, as established by history, psychiatric examination and a structured diagnostic interview (Kiddie-Sads-Present and Lifetime Version)
Patients, whose symptoms are adequately controlled by a stable and well-tolerated dose of a immediate release methylphenidate equivalent of 20mg for one month before screening.
Exclusion Criteria:
Patients with comorbid psychiatric conditions with symptoms requiring current pharmacological treatment (e.g. major depression, psychosis).
Patients who are taking any concomitant medications likely to interfere with the study drug or confound efficacy or safety assessments, e.g.
Tricyclic antidepressants, buproprion, clonidine, buspirone 2 weeks before randomization.
Atomoxetine 2 weeks before randomization.
Fluoxetine or antipsychotics 1 month before randomization.
Pemoline and amphetamines 1 week before randomization.
Patients with a known non-response to methylphenidate.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigational Site
City
Freiburg
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Placebo-Controlled Comparison of Two Different Brands of Modified-Release Oral Dosage Forms Regarding Safety and Efficacy in Children With Attention Deficit Hyperactivity Disorder (ADHD) Aged 6 - 14
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