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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Tracking Information | ||||
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First Submitted Date | September 21, 2005 | |||
First Posted Date | September 23, 2005 | |||
Results First Submitted Date | April 18, 2017 | |||
Results First Posted Date | August 14, 2017 | |||
Last Update Posted Date | August 14, 2017 | |||
Study Start Date | July 2002 | |||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Drug (Valproic Acid or Carbamazepine) Metabolite Profiles in Urine [ Time Frame: urine samples (overnight collections) collected longitudinally through study completion for time frame ranging from 2-5 years ] 1. To examine the individual metabolic profiles of pediatric patients receiving carbamazepine or valproate therapy, in an attempt to determine the identities of the reactive metabolites or, alternatively, the identities of those metabolites that serve as potential precursors to reactive species (e.g., through conjugation with detoxifying compounds such as glutathione).
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Original Primary Outcome Measures | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures |
Age-related Changes in Bioactivation [ Time Frame: urine samples (overnight collections) collected longitudinally through study completion for time frame ranging from 2-5 years ] 2. To determine if age-related differences exist regarding the ability of pediatric patients to bioactivate carbamazepine or valproate to reactive metabolites. Data provided below reflect the slope of the least squares regression.
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Original Secondary Outcome Measures | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Pathogenesis of Adverse Drug Reactions | |||
Official Title | The Role of Drug Metabolizing Enzymes in the Pathogenesis Adverse Drug Reactions in Children | |||
Brief Summary | The purpose of the study is to examine the individual metabolic profiles of pediatric patients receiving carbamazepine or valproate therapy, in an attempt to determine identities of the reactive metabolites or, alternatively, the identities of those metabolites that serve as potential precursors to reactive species. | |||
Detailed Description | Adverse drug reactions can be broadly defined as any undesirable response associated with therapeutic drug use. A simple and clinically useful classification is to divide adverse events into those that are dose-dependent and largely predictable from the known pharmacologic properties of the compound in question, and those that are dependent on characteristics unique to susceptible individuals, or idiosyncratic in nature. The long term objective of this research is to characterize the mechanisms responsible for the pathogenesis of idiosyncratic hypersensitivity reactions in children, particularly those involving carbamazepine and other aromatic anticonvulsants. The study is divided into two phases. Phase 1 of the study involves collecting urine from 50 patients taking CBZ therapeutically. Participants will be asked to provide a spot urine sample during routine health visits. The urine will be analyzed for the presence of CBZ and its metabolites. In Phase 2 of the study, urine will be collected from patients taking either CBZ or VPA therapeutically. If blood samples are drawn from these patients for medical purposes not related to this study the residual blood sample will be recovered before it is discarded for use in genotyping analysis. Participants will be asked to provide a urine sample covering one complete dosing interval of CBZ or VPA (preferably overnight). Patients will also be followed longitudinally, with urine collections at each clinic visit over at least a two year period. |
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Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: Urine DNA (source: blood or saliva)
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Sampling Method | Probability Sample | |||
Study Population | Pediatric patients of both genders between 1 and 16 years of age receiving carbamazepine (CBZ) or valproic acid (VPA) as monotherapy or polytherapy | |||
Condition | Seizures | |||
Intervention | Other: No intervention; Urine Collection
Urine collected from children receiving carbamazepine or valproic acid as part of their clinical management
Other Names:
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Study Groups/Cohorts | Patients receiving Carbamazepine or Valproic Acid
Intervention: Other: No intervention; Urine Collection
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Publications * | Not Provided | |||
* 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 | Completed | |||
Actual Enrollment |
274 | |||
Original Enrollment |
120 | |||
Actual Study Completion Date | March 2010 | |||
Actual Primary Completion Date | March 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 1 Year to 16 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00224952 | |||
Other Study ID Numbers | PPRU 10606 NIH Grant HD044239 |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Steve Leeder, Children's Mercy Hospital Kansas City | |||
Study Sponsor | Children's Mercy Hospital Kansas City | |||
Collaborators |
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Investigators |
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PRS Account | Children's Mercy Hospital Kansas City | |||
Verification Date | August 2017 |