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NCT01369615 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
A Phase 3 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 23
- Enrollment target
NCT01369615: Completed Phase 3 study, sponsored by Purdue Pharma.
NCT01369615 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 23 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01369615, a Phase 3 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy who completed the 4 -week treatment period in OTR3001.
Primary Outcome
Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale \[UMSS\]). Safety variables were summarized descriptively within age group for the extension safety population.
Interventions
- DRUG Oxycodone hydrochloride controlled-release tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
What the finished NCT01369615 record still lists
NCT01369615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Oxycodone hydrochloride controlled-release tablets is the first listed.
NCT01369615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01369615 about?
NCT01369615 is a clinical study titled "Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001". The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy who completed...
What is the current status of trial NCT01369615?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 23 participants. The study started on 2011-10. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01369615?
The interventions under investigation include: Oxycodone hydrochloride controlled-release tablets (DRUG).
Who is sponsoring clinical trial NCT01369615?
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 NCT01369615's enrollment target sits among peer trials
23 1952nd of 2000 higher than 48 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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