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NCT01428583 · ClinicalTrials.gov registry record · Phase 3
Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 395
- Enrollment target
NCT01428583: Completed Phase 3 study, sponsored by Pfizer.
NCT01428583 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 395 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01428583, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 395 participants
- Enrollment target
Study Summary
The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.
Primary Outcome
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE that was attributed to study drug in a participant who received study drug was defined as an adverse reaction. Treatment-emergent are events between first dose of study drug and up to end of study (2 weeks post-end of month 12) that were absent before treatment or that worsened relative to pretreatment state.
Interventions
- DRUG oxycodone HCl and naltrexone HCl extended-release capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2010-12 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT01428583 record still lists
NCT01428583 is an interventional study that assigns participants to a tested intervention. The registered 395 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 1 intervention - of which oxycodone HCl and naltrexone HCl extended-release capsules is the first listed.
NCT01428583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01428583 about?
NCT01428583 is a clinical study titled "Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain". The study will provide information to assess the benefits versus risks of extended exposure to oxycodone HCl and naltrexone HCl extended-release capsules in a chronic noncancer pain population.
What is the current status of trial NCT01428583?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 395 participants. The study started on 2010-12. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01428583?
The interventions under investigation include: oxycodone HCl and naltrexone HCl extended-release capsules (DRUG).
Who is sponsoring clinical trial NCT01428583?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01428583's enrollment target sits among peer trials
395 965th of 2000 higher than 1,034 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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