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NCT01162304 · ClinicalTrials.gov registry record · Phase 4
Open-Label Trial Comparing Oxycodone Medications
A Phase 4 study, sponsored by University of Rochester.
- Terminated
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
NCT01162304: Clinical Trial Phase 4 study, sponsored by University of Rochester.
NCT01162304 is a Phase 4 study that was terminated before completion, run by University of Rochester. The registered enrollment target is 18 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01162304, a Phase 4 study, was terminated before completion, sponsored by University of Rochester.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
Study Summary
The investigators hypothesize that subjects will have greater pain relief when taking IR-oxycodone compared with ER-oxycodone for several reasons. The ability to take a varying amount of medication at six different points over the course of a day will allow patients to take as much (or as little) medication as they need to control their pain. In addition, the ability to vary the medication doses in this way will give them a greater sense of control, which will also contribute to greater pain relief. Similarly, the investigators predict that patients will show greater benefits with IR-oxycodone on the measures of physical and emotional functioning. Because there is relatively little data on sleep apnea in chronic pain patients (Webster et al., 2008), these assessments are exploratory and not hypothesis-based. Finally, although it is typically thought that the abuse liability of IR-opioid medications is greater than for ER-medications, the data on which this belief are based have not involved systematic studies of patients with chronic pain; the assessments of abuse liability will therefore also be exploratory.
Primary Outcome
The primary outcome measure for this clinical trial will be pain relief documented in the subjects' daily pain diaries. Specifically, the average of the daily pain ratings recorded by subjects during the final weeks of the two treatment periods will be compared. The treatment comparison of interest is IR-oxycodone vs. ER-oxycodone, which will be tested at the p \< 0.05 level using a two-tailed test.
Interventions
- DRUG Extended Release Oxycodone
- DRUG Immediate Release Oxycodone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-03 |
| Est. Completion | 2013-12 |
| Phase | Phase 4 |
Why NCT01162304 stopped before completion
NCT01162304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Extended Release Oxycodone is the first listed.
NCT01162304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01162304 about?
NCT01162304 is a clinical study titled "Open-Label Trial Comparing Oxycodone Medications". The investigators hypothesize that subjects will have greater pain relief when taking IR-oxycodone compared with ER-oxycodone for several reasons. The ability to take a varying amount of medication at six different points over the course of a day will allow patients to take as much (or as little) me...
What is the current status of trial NCT01162304?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2010-03. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01162304?
The interventions under investigation include: Extended Release Oxycodone (DRUG), Immediate Release Oxycodone (DRUG).
Who is sponsoring clinical trial NCT01162304?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01162304's enrollment target sits among peer trials
18 1842nd of 2000 higher than 147 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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