Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
NCT00904670
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- Male or female from 6 to 12 years of age at the time of screening, inclusive.
- Diagnosis of ADHD by a Psychiatrist, Psychologist, Developmental Pediatrician, or a Pediatrician meeting diagnostic criteria for ADHD (DSM-IV). A Schedule for Affective Disorders and Schizophrenia for School Age Children (K-SADS)16 was administered on all subjects to assist in diagnostic process.
- A clinician-administered Clinical Global Impression of Severity (CGI-S) score of 3 or greater. An Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) score at screening or baseline greater than or equal to the 90th percentile normative values for gender and age in at least one of the following categories: the hyperactive-impulsive subscale, inattentive subscale or the total score.
- Subject must have been in need of pharmacological treatment for ADHD.
- Subjects taking a medication to control ADHD at the time of screening must have been experiencing suboptimal efficacy, a safety or tolerability issue or in need of a long-acting liquid formulation.
- For subjects taking any daily medication at screening aside from ADHD medication: parent or legal guardian agreed that there would be no elective changes in subject's medications during the study (10 weeks total).
- Excluded comorbid psychiatric diagnoses: DSM-IV Axis I diagnosis (active) other than
ADHD, with the exception of Specific Phobias, Learning Disorders, Motor Skills
Disorders, Communication Disorders, Oppositional Defiant Disorder, Elimination
Disorders, Sleep Disorders, and Adjustment Disorders.
- Clinically significant cognitive impairment as assessed in the clinical judgment of
the Investigator. In cases where this was not clear, study staff were permitted to
administer a Wechsler Abbreviated Scale of Intelligence (WASI)17 to estimate the
intelligence quotient (IQ). Significant cognitive impairment for this protocol was
defined as an estimated IQ below 80.
- Subjects with chronic medical illnesses including seizure disorder (excluding a
history of febrile seizures), severe hypertension, thyroid disease, structural cardiac
disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, glaucoma,
Tourette's Disorder, family history of Tourette's Disorder or tics.
- Use of monoamine oxidase inhibitors within 30 days of the screening visit.
- Use of any psychotropic medication (except sedative hypnotics prescribed as a sleep
aid at a stable dose for at least 30 days prior to screening, at bedtime only). Use of
stimulant medication for control of ADHD at screening was permitted if inclusion
criterion number 6 was met.
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Descriptive Information | ||||
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Brief Title ICMJE | Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) | |||
Official Title ICMJE | NWP06 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)- A Laboratory Classroom Study | |||
Brief Summary | The objective of this study was to establish that an optimal dose of Quillivant XR oral suspension would result in a significant reduction in signs and symptoms of ADHD compared to placebo treatment in pediatric patients ages 6-12 years with ADHD. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Attention Deficit Hyperactivity Disorder | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
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Publications * | Wigal SB, Childress AC, Belden HW, Berry SA. NWP06, an extended-release oral suspension of methylphenidate, improved attention-deficit/hyperactivity disorder symptoms compared with placebo in a laboratory classroom study. J Child Adolesc Psychopharmacol. 2013 Feb;23(1):3-10. doi: 10.1089/cap.2012.0073. Epub 2013 Jan 5. | |||
* 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 | 45 | |||
Original Estimated Enrollment ICMJE | 40 | |||
Actual Study Completion Date ICMJE | August 2009 | |||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 | NCT00904670 | |||
Other Study ID Numbers ICMJE | NWP06-ADD-100 B7491007 | |||
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 |
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PRS Account | Pfizer | |||
Verification Date | May 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |