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NCT01240863 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain 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
- 391
- Enrollment target
NCT01240863: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01240863 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 391 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
NCT01240863, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 391 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate efficacy of hydrocodone extended-release (ER) tablets compared with placebo in alleviating moderate to severe pain in patients with osteoarthritis or low back pain as assessed by the weekly Average Pain Intensity (API) at week 12.
Primary Outcome
The primary efficacy variable was the change from baseline to week 12 in the wAPI. The API over the previous 24 hours, based on the 11-point Numerical Rating Scale (NRS 11), was collected daily by e-diary. The Week 12 wAPI scores from the previous 7 days were calculated for each study visit and averaged. The baseline wAPI score was calculated by averaging API scores from 3 to 12 days when the successful dose of hydrocodone extended release was confirmed at the end of the open label titration per
Interventions
- DRUG Placebo
- DRUG Hydrocodone ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 391 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
What the finished NCT01240863 record still lists
NCT01240863 is an interventional study that assigns participants to a tested intervention. The registered 391 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 2 interventions - of which Placebo is the first listed.
NCT01240863 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01240863 about?
NCT01240863 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) for Relief of Moderate to Severe Pain in Patients With Osteoarthritis or Low Back Pain Who Require Opioid Treatment for an Extended Period of Time". The primary objective of this study is to evaluate efficacy of hydrocodone extended-release (ER) tablets compared with placebo in alleviating moderate to severe pain in patients with osteoarthritis or low back pain as assessed by the weekly Average Pain Intensity (API) at week 12.
What is the current status of trial NCT01240863?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 391 participants. The study started on 2010-11. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01240863?
The interventions under investigation include: Placebo (DRUG), Hydrocodone ER (DRUG).
Who is sponsoring clinical trial NCT01240863?
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 NCT01240863's enrollment target sits among peer trials
391 968th of 2000 higher than 1,033 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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