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

NCT00254878 | Completed Phase 3

• 1 other identifier: CRIT124DDE01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

ADHD, Methylphenidate hydrochloride, modified-release

Outcome Measures

Primary Outcomes (1)

• Attention and deportment measured at 1.5, 3.0 and 4.5 hours after drug intake

Secondary Outcomes (2)

• 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

Interventions

Methylphenidate hydrochloride DRUG

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigational Site

Freiburg im Breisgau, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 15, 2005
• First Posted: November 17, 2005
• Study Start: October 1, 2005
• Study Completion: February 1, 2006
• Last Updated: December 21, 2007

Record last verified: 2007-12

Locations

DE (1)