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NCT01205256 · ClinicalTrials.gov registry record · Phase 3
IRB-HSR# 14145 R,S Methadone: Analgesia and Pharmacokinetics in Adolescents Undergoing Scoliosis Correction
A Phase 3 study of Scoliosis, sponsored by University of Virginia.
- Completed
- Registry status
- Phase 3
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT01205256: Completed Phase 3 study of Scoliosis, sponsored by University of Virginia.
NCT01205256 is a Phase 3 study of Scoliosis that has completed, run by University of Virginia. The registered enrollment target is 11 participants, below the 1,216-participant average among 17 other Scoliosis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01205256, a Phase 3 study of Scoliosis, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot study to determine the pharmacokinetics of (R,S) methadone in adolescents. A total of approximately 15 patients will be required. The purpose is to determine the levels of R, S methadone at various time intervals after drug administration. Patients will receive methadone 0.25 mg/kg IV at induction and a standardized anesthetic of remifentanil and propofol. At the conclusion of surgery (45 minutes prior to the completion), the patients will receive a loading dose of morphine based on respiratory rate. A morphine PCA will be utilized for postoperative analgesia. Pharmacokinetic data will be collected in addition to VAS scores, patient and parental satisfaction with analgesia, and a functional pain assessment.
Primary Outcome
Tmax (time to maximum methadone concentration) Cmax (maximum concentration) T1/2 (half-life) AUC last (area under the curve from time 0 to last sample point) AUC inf (area under the curve from time 0 to infinity) VZ (Volume of distribution in the terminal phase) CL (clearance)
Conditions Studied
Interventions
- DRUG methadone
Study Locations (1)
Virginia
- University of Virginia Health System - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2009-03 |
| Est. Completion | 2010-04 |
| Phase | Phase 3 |
What the finished NCT01205256 record still lists
NCT01205256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,216-participant average among 17 other Scoliosis trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Scoliosis appearing as the primary indexed condition, and to 1 intervention - of which methadone is the first listed.
NCT01205256 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT01205256 about?
NCT01205256 is a clinical study titled "IRB-HSR# 14145 R,S Methadone: Analgesia and Pharmacokinetics in Adolescents Undergoing Scoliosis Correction". This is a pilot study to determine the pharmacokinetics of (R,S) methadone in adolescents. A total of approximately 15 patients will be required. The purpose is to determine the levels of R, S methadone at various time intervals after drug administration. Patients will receive methadone 0.25 mg/kg I...
What is the current status of trial NCT01205256?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 11 participants. The study started on 2009-03. Estimated completion is 2010-04.
What conditions does trial NCT01205256 study?
This clinical trial studies the following conditions: Scoliosis.
What interventions are being tested in trial NCT01205256?
The interventions under investigation include: methadone (DRUG).
Who is sponsoring clinical trial NCT01205256?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01205256 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Scoliosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01205256's enrollment target sits among peer trials
11 18th of 17 the lowest of 17 other Scoliosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Scoliosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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