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NCT01115569 · ClinicalTrials.gov registry record · Phase 3
Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain
A Phase 3 study, sponsored by Zogenix.
- Completed
- Registry status
- Phase 3
- Development phase
- 424
- Enrollment target
NCT01115569: Completed Phase 3 study, sponsored by Zogenix.
NCT01115569 is a Phase 3 study that has completed, run by Zogenix. The registered enrollment target is 424 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01115569, a Phase 3 study, has completed, sponsored by Zogenix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 424 participants
- Enrollment target
Study Summary
This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.
Primary Outcome
Numeric Rating Scale (NRS) for Pain (0-10; where 0 = no pain, 10 = worst pain imaginable) recorded up to 54 weeks, starting at screening through end of study. Lower number equals better outcome.
Interventions
- DRUG Hydrocodone Bitartrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 424 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
What the finished NCT01115569 record still lists
NCT01115569 is an interventional study that assigns participants to a tested intervention. The registered 424 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 (45% lower).
The record links to 0 conditions, and to 1 intervention - of which Hydrocodone Bitartrate is the first listed.
NCT01115569 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01115569 about?
NCT01115569 is a clinical study titled "Long-Term Study of Hydrocodone Bitartrate Controlled-release Capsules in Subjects With Chronic Pain". This Phase 3, multi-center study will evaluate the long-term safety and tolerability of hydrocodone bitartrate controlled release capsule (HC-CR) at daily doses of 40 mg or more in subjects with moderate to severe chronic pain. Long-term maintenance of HC-CR efficacy will be evaluated.
What is the current status of trial NCT01115569?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 424 participants. The study started on 2010-05. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01115569?
The interventions under investigation include: Hydrocodone Bitartrate (DRUG).
Who is sponsoring clinical trial NCT01115569?
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 NCT01115569's enrollment target sits among peer trials
424 884th of 2000 higher than 1,116 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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