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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 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 23 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01369615
The ClinicalTrials.gov registry entry for NCT01369615 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Purdue Pharma, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Oxycodone hydrochloride controlled-release tablets is the first listed.
NCT01369615 reports 0 study locations.
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.
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