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

ADHD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254878
• Other study ID #: CRIT124DDE01
• Status: Completed
• Phase: Phase 3
• First received: November 15, 2005
• Last updated: December 17, 2007
• Start date: October 2005
• Est. completion date: February 2006

Study information

• Verified date: December 2007
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 2006
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Drug:
• Methylphenidate hydrochloride

Locations

Country	Name	City	State
Germany	Novartis Investigational Site	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attention and deportment measured at 1.5, 3.0 and 4.5 hours after drug intake
Secondary	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
Secondary	Safety of 7 week's treatment with two different brands of modified-release oral dosage forms of methylphenidate-HCl