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NCT01081912 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain
A Phase 3 study, sponsored by Zogenix.
- Completed
- Registry status
- Phase 3
- Development phase
- 510
- Enrollment target
NCT01081912: Completed Phase 3 study, sponsored by Zogenix.
NCT01081912 is a Phase 3 study that has completed, run by Zogenix. The registered enrollment target is 510 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01081912, a Phase 3 study, has completed, sponsored by Zogenix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 510 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.
Primary Outcome
Change in average pain intensity as measured daily by Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) comparing HC-ER with Placebo. Lower number equals better outcome.
Interventions
- DRUG Placebo
- DRUG Hydrocodone bitartrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 510 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
What the finished NCT01081912 record still lists
NCT01081912 is an interventional study that assigns participants to a tested intervention. The registered 510 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 (34% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01081912 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01081912 about?
NCT01081912 is a clinical study titled "Phase 3 Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Low Back Pain". The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.
What is the current status of trial NCT01081912?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 510 participants. The study started on 2010-03. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01081912?
The interventions under investigation include: Placebo (DRUG), Hydrocodone bitartrate (DRUG).
Who is sponsoring clinical trial NCT01081912?
This trial is sponsored by Zogenix, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01081912's enrollment target sits among peer trials
510 729th of 2000 higher than 1,264 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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