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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 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 391 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01240863
The ClinicalTrials.gov registry entry for NCT01240863 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 391 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Teva Branded Pharmaceutical Products R&D, which has 167 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01240863 reports 0 study locations.
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.
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