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NCT01324570 · ClinicalTrials.gov registry record · Phase 3
Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children
A Phase 3 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 41
- Enrollment target
NCT01324570: Completed Phase 3 study, sponsored by Purdue Pharma.
NCT01324570 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 41 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01324570, a Phase 3 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 41 participants
- Enrollment target
Study Summary
The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.
Primary Outcome
Safety assessments consisted of reports of AEs, vital signs (blood pressure, pulse rate, respiratory rate, and temperature), weight, hemoglobin-oxygen saturation measured by pulse oximetry (SpO2), clinical laboratory tests, somnolence (assessed by the University of Michigan Sedation Scale \[UMSS\]), conventional 12-lead electrocardiograms (ECGs), and 24-hour digital 12-lead ECGs (Holter monitor). Safety variables were summarized descriptively within age group for the safety population.
Interventions
- DRUG Buprenorphine transdermal system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2011-07 |
| Est. Completion | 2016-05 |
| Phase | Phase 3 |
What the finished NCT01324570 record still lists
NCT01324570 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine transdermal system is the first listed.
NCT01324570 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01324570 about?
NCT01324570 is a clinical study titled "Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children". The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.
What is the current status of trial NCT01324570?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2011-07. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01324570?
The interventions under investigation include: Buprenorphine transdermal system (DRUG).
Who is sponsoring clinical trial NCT01324570?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01324570's enrollment target sits among peer trials
41 1877th of 2000 higher than 123 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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