NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)

NCT ID: NCT01654250

Last Updated: 2016-02-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-10-31

Brief Summary

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The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

NWP09

Group Type EXPERIMENTAL

NWP09

Intervention Type DRUG

Methylphenidate, variable dose, daily dosing, 1 week duration

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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NWP09

Methylphenidate, variable dose, daily dosing, 1 week duration

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition

Exclusion Criteria

* Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Clinical Study Centers, LLC

Little Rock, Arkansas, United States

Site Status

Laboratory School

Huntington Beach, California, United States

Site Status

UC Irvine Child Development Center

Irvine, California, United States

Site Status

UC Irvine - Hewitt Hall

Irvine, California, United States

Site Status

Florida Clinical Research Center, LLC

Bradenton, Florida, United States

Site Status

Woodland Community Church (Laboratory School)

Bradenton, Florida, United States

Site Status

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, United States

Site Status

Bayou City Research, Ltd.

Houston, Texas, United States

Site Status

Westex Clinical Investigations

Lubbock, Texas, United States

Site Status

Countries

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United States

References

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Wigal SB, Childress A, Berry SA, Belden H, Walters F, Chappell P, Sherman N, Orazem J, Palumbo D. Efficacy and Safety of a Chewable Methylphenidate Extended-Release Tablet in Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2017 Oct;27(8):690-699. doi: 10.1089/cap.2016.0177. Epub 2017 May 30.

Reference Type DERIVED
PMID: 28557548 (View on PubMed)

Related Links

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Other Identifiers

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B7491005

Identifier Type: OTHER

Identifier Source: secondary_id

NWP09-ADHD-300

Identifier Type: -

Identifier Source: org_study_id

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