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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 is a Phase 3 study that has completed, run by Zogenix. The registered enrollment target is 424 participants.
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.
Interventions
- DRUG Hydrocodone Bitartrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 424 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01115569
The ClinicalTrials.gov registry entry for NCT01115569 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 424 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zogenix, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hydrocodone Bitartrate is the first listed.
NCT01115569 reports 0 study locations.
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.
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