drugset / Trial / NCT01240863
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
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2010-11
- Primary completion
- 2011-08
- Completion
- 2011-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydrocodone ER | Unknown | 15 mg | — |
| Subject | Hydrocodone ER | Unknown | 30 mg | — |
| Subject | Hydrocodone ER | Unknown | 45 mg | — |
| Subject | Hydrocodone ER | Unknown | 60 mg | — |
| Subject | Hydrocodone ER | Unknown | 90 mg | — |