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The study was cancelled prior to the enrollment of any participants.
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A 6-week double-blind study to evaluate the safety and efficacy of Quillichew extended release chewable tablets in 4-5 year old children with attention deficit hyperactivity disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quillichew ERCT | Active Comparator | Quillichew ERCT |
|
| Placebo to match Quillichew ERCT | Placebo Comparator | Placebo to match Quillichew ERCT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylphenidate HCl ERCT | Drug | methylphenidate HCl ERCT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety-incidence of treatment emergent adverse events | incidence of treatment emergent adverse events | 6 months |
| Attention Deficit Hyperactivity Rating Scale - IV (ADHD RS-IV) Preschool-Home Version | 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 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of adverse events | incidence of adverse events | 6 weeks |
| Clinical Global Impression of Improvement (CGI-I) Scale Score | 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. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
| To obtain contact information for a study center near you, click here. | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Placebo |
| Drug |
Placebo to Match Quillichew ERCT |
|
| weeks 1-6 |
| Intellectual Performance of Children Using Child Behavior Checklist 4-18 Years (CBCL 4-18) | 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). | Weeks 1-6 |
| Children's Global Assessment Scale (CGAS) | 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. | Week 6 |
| Mean Clinical Global Impression - Severity (CGI-S) score | 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 | Weeks 1-6 |
| To obtain contact information for a study center near you, click here. | View source |
| To obtain contact information for a study center near you, click here. | View source |
| To obtain contact information for a study center near you, click here. | View source |
| To obtain contact information for a study center near you, click here. | View source |