NWP06 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00904670
First received: May 18, 2009
Last updated: April 2, 2013
Last verified: April 2013
| Tracking Information | |||||
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| First Received Date ICMJE | May 18, 2009 | ||||
| Last Updated Date | April 2, 2013 | ||||
| Start Date ICMJE | May 2009 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
SKAMP [ Time Frame: Weeks 5-6 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00904670 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
PERMP [ Time Frame: Weeks 5-6 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | NWP06 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD) | ||||
| Official Title ICMJE | NWP06 in the Treatment of Children With ADHD: A Laboratory Classroom Study | ||||
| Brief Summary | The purpose of this study is to determine whether NWP06 is effective in the treatment of ADHD in children ages 6-12. |
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| Detailed Description | This is a randomized, double-blind, placebo-controlled, crossover design, optimized-dose, Phase 3 trial to evaluate the safety and efficacy of NWP06 in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Attention Deficit Hyperactivity Disorder | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 45 | ||||
| Completion Date | August 2009 | ||||
| Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00904670 | ||||
| Other Study ID Numbers ICMJE | NWP06-ADD-100 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Pfizer | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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