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NCT00147394 · ClinicalTrials.gov registry record · Phase 1
Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)
A Phase 1 study of Child Development Disorders, Pervasive, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 5
- Study locations
NCT00147394: Completed Phase 1 study of Child Development Disorders, Pervasive, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT00147394 is a Phase 1 study of Child Development Disorders, Pervasive that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 100 participants, above the 84-participant average among 4 other Child Development Disorders, Pervasive trials with a reported enrollment target (19% higher). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00147394, a Phase 1 study of Child Development Disorders, Pervasive, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this research is to study the pharmacokinetics of risperidone in a group of pediatric patients with Pervasive Developmental Disorder (PDD). The study will determine how much risperidone and its breakdown product, 9-hydroxy-risperidone, is in the blood following the patient's usual daily dose. The study is designed to look at how fast children absorb, breakdown, and eliminate risperidone.
Conditions Studied
Interventions
- DRUG Risperidone
Study Locations (5)
Ohio
- Cincinnati Children's Hospital - Cincinnati
- Rainbow Babies and Children's Hospital - Cleveland
- The Ohio State University Medical Center - Columbus
Michigan
- Children's Hospital of Michigan/Wayne State University - Detroit
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2001-12 |
| Est. Completion | 2004-06 |
| Phase | Phase 1 |
What the finished NCT00147394 record still lists
NCT00147394 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 84-participant average among 4 other Child Development Disorders, Pervasive trials with a reported enrollment target (19% higher).
The record links to 1 condition, with Child Development Disorders, Pervasive appearing as the primary indexed condition, and to 1 intervention - of which Risperidone is the first listed.
NCT00147394 lists 5 locations in 3 states (Ohio, Michigan, North Carolina).
Frequently Asked Questions
What is clinical trial NCT00147394 about?
NCT00147394 is a clinical study titled "Risperidone Pharmacokinetics in Children With Pervasive Developmental Disorder (PDD)". The purpose of this research is to study the pharmacokinetics of risperidone in a group of pediatric patients with Pervasive Developmental Disorder (PDD). The study will determine how much risperidone and its breakdown product, 9-hydroxy-risperidone, is in the blood following the patient's usual dai...
What is the current status of trial NCT00147394?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2001-12. Estimated completion is 2004-06.
What conditions does trial NCT00147394 study?
This clinical trial studies the following conditions: Child Development Disorders, Pervasive.
What interventions are being tested in trial NCT00147394?
The interventions under investigation include: Risperidone (DRUG).
Who is sponsoring clinical trial NCT00147394?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00147394 being conducted?
This trial has 5 study locations across Michigan, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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