Placebo-Controlled Comparison of Two Different Brands of... | NCT00254878

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Not provided

Completion Date

Feb 2006Actual

First Submitted Date

Nov 15, 2005

First Submission Date that Met QC Criteria

Nov 16, 2005

First Posted Date

Nov 17, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2007

Last Update Posted Date

Dec 21, 2007Estimated

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

130

Name	Type	Description	Arm Group Labels	Other Names
Methylphenidate hydrochloride	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Attention and deportment measured at 1.5, 3.0 and 4.5 hours after drug intake

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds