Pathogenesis of Adverse Drug Reactions
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ClinicalTrials.gov Identifier: NCT00224952 |
Recruitment Status :
Completed
First Posted : September 23, 2005
Results First Posted : August 14, 2017
Last Update Posted : August 14, 2017
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Sponsor:
Children's Mercy Hospital Kansas City
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Utah
University of Louisville
Information provided by (Responsible Party):
Steve Leeder, Children's Mercy Hospital Kansas City
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Study Type | Observational |
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Study Design | Observational Model: Case-Only; Time Perspective: Prospective |
Condition |
Seizures |
Intervention |
Other: No intervention; Urine Collection |
Enrollment | 274 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Carbamazepine Phase 1 | Carbamazepine Phase 2 | Valporic Acid Phase 2 |
---|---|---|---|
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No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management | No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management | No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management |
Period Title: Overall Study | |||
Started | 53 | 87 | 134 |
Completed | 53 | 87 | 134 |
Not Completed | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Carbamazepine Phase 1 | Carbamazepine Phase 2 | Valporic Acid Phase 2 | Total | |
---|---|---|---|---|---|
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No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management | No intervention; Urine Collection: Urine collected from children receiving carbamazepine as part of their clinical management | No intervention; Urine Collection: Urine collected from children receiving valproic acid as part of their clinical management | Total of all reporting groups | |
Overall Number of Baseline Participants | 53 | 87 | 134 | 274 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 53 participants | 87 participants | 134 participants | 274 participants | |
9.8 (4.6) | 11.0 (4.0) | 10.2 (4.1) | 10.38 (4.16) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 53 participants | 87 participants | 134 participants | 274 participants | |
Female |
18 34.0%
|
43 49.4%
|
56 41.8%
|
117 42.7%
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Male |
35 66.0%
|
44 50.6%
|
78 58.2%
|
157 57.3%
|
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 53 participants | 87 participants | 134 participants | 274 participants | |
Hispanic or Latino |
1 1.9%
|
6 6.9%
|
7 5.2%
|
14 5.1%
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Not Hispanic or Latino |
52 98.1%
|
81 93.1%
|
127 94.8%
|
260 94.9%
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Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 53 participants | 87 participants | 134 participants | 274 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
0 0.0%
|
2 2.3%
|
2 1.5%
|
4 1.5%
|
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Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
4 7.5%
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0 0.0%
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14 10.4%
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18 6.6%
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White |
47 88.7%
|
80 92.0%
|
111 82.8%
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238 86.9%
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More than one race |
2 3.8%
|
5 5.7%
|
4 3.0%
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11 4.0%
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Unknown or Not Reported |
0 0.0%
|
0 0.0%
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3 2.2%
|
3 1.1%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | J. Steven Leeder Pharm D, PhD |
Organization: | The Children's Mercy Hospital |
Phone: | 816-234-3059 |
EMail: | sleeder@cmh.edu |
Responsible Party: | Steve Leeder, Children's Mercy Hospital Kansas City |
ClinicalTrials.gov Identifier: | NCT00224952 |
Other Study ID Numbers: |
PPRU 10606 NIH Grant HD044239 |
First Submitted: | September 21, 2005 |
First Posted: | September 23, 2005 |
Results First Submitted: | April 18, 2017 |
Results First Posted: | August 14, 2017 |
Last Update Posted: | August 14, 2017 |