NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)

NCT01654250

Last updated date
Study Location
Clinical Study Centers, LLC
Little Rock, Arkansas, 72211, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Attention Deficit Hyperactivity Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-12 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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Advanced Information
Descriptive Information
Brief Title  ICMJE NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Official Title  ICMJE A Multicenter, Dose-optimized, Double-blind, Randomized, Placebo-controlled Study To Evaluate The Efficacy Of Nwp09 In Pediatric Patients With Attention Deficit Hyperactivity Disorder (Adhd) In A Laboratory Classroom
Brief Summary The safety and efficacy of a chewable formulation of extended-release methylphenidate will be studied in children with ADHD
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Hyperactivity Disorder
Intervention  ICMJE
  • Drug: NWP09
    Methylphenidate, variable dose, daily dosing, 1 week duration
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Active
    NWP09
    Intervention: Drug: NWP09
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2012)
90
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2012)
80
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01654250
Other Study ID Numbers  ICMJE NWP09-ADHD-300
B7491005 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP