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NCT01223365 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 330
- Enrollment target
NCT01223365: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01223365 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 330 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01223365, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 330 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety of hydrocodone extended-release tablets when used over a 12-month period in patients with chronic pain, as assessed by adverse events, clinical laboratory results, vital signs measurements, electrocardiogram results, physical examination findings, pure tone audiometry, and concomitant medication usage.
Primary Outcome
An adverse event (AE) was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly
Interventions
- DRUG Hydrocodone ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-09 |
| Phase | Phase 3 |
What the finished NCT01223365 record still lists
NCT01223365 is an interventional study that assigns participants to a tested intervention. The registered 330 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 (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Hydrocodone ER is the first listed.
NCT01223365 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01223365 about?
NCT01223365 is a clinical study titled "Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time". The primary objective of this study is to evaluate the safety of hydrocodone extended-release tablets when used over a 12-month period in patients with chronic pain, as assessed by adverse events, clinical laboratory results, vital signs measurements, electrocardiogram results, physical examination ...
What is the current status of trial NCT01223365?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 330 participants. The study started on 2010-10. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01223365?
The interventions under investigation include: Hydrocodone ER (DRUG).
Who is sponsoring clinical trial NCT01223365?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01223365's enrollment target sits among peer trials
330 1066th of 2000 higher than 927 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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