A 6-week Study to Evaluate the Safety and Efficacy of Quillichew ERCT in 4-5 Year Old Children With ADHD.
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|ClinicalTrials.gov Identifier: NCT03580005|
Recruitment Status : Withdrawn (The study was cancelled prior to the enrollment of any participants.)
First Posted : July 9, 2018
Last Update Posted : November 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder (ADHD) Attention Deficit Hyperactivity Disorder||Drug: methylphenidate HCl ERCT Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Quillichew (Methylphenidate Hydrochloride (Hcl)) Extended Release Chewable Tablets (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)|
|Estimated Study Start Date :||October 31, 2018|
|Estimated Primary Completion Date :||October 12, 2021|
|Estimated Study Completion Date :||October 12, 2021|
Active Comparator: Quillichew ERCT
Drug: methylphenidate HCl ERCT
methylphenidate HCl ERCT
Placebo Comparator: Placebo to match Quillichew ERCT
Placebo to match Quillichew ERCT
Placebo to Match Quillichew ERCT
- Safety-incidence of treatment emergent adverse events [ Time Frame: 6 months ]incidence of treatment emergent adverse events
- Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version [ Time Frame: 6 weeks ]Change from Baseline to end of double-blind treatment in the total score of the Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version
- incidence of adverse events [ Time Frame: 6 weeks ]incidence of adverse events
- Clinical Global Impression of Improvement (CGI-I) Scale Score [ Time Frame: weeks 1-6 ]CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: "Compared to your subject's condition at the beginning of treatment, how much has your subject changed?". Improvement was compared to baseline and was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
- Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18) [ Time Frame: Weeks 1-6 ]CBCL was standardized for children ages 4 to 18 years and measured child internalizing and externalizing behaviors and total problems. The 4-18 years' checklist contains 140 questions and responses were recorded on a Likert scale: 0 = Not True, 1 = Somewhat or Sometimes True, 2 = Very True or Often True. The range of possible values was 0-280 (0=good to 280=worst).
- Children's Global Assessment Scale (CGAS) [ Time Frame: Week 6 ]CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 (most impaired) to 100 (healthiest); higher levels indicate greater health, with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the "normal" range; lower score indicates need for increased supervision.
- Mean Clinical Global Impression - Severity (CGI-S) score [ Time Frame: Weeks 1-6 ]CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580005
|Study Director:||Pfizer CT.gov Call Center||Pfizer|