drugset / Trial / NCT00549042
Study to Test the Effectiveness of Controlled-Release OROS® Hydromorphone HCl Compared to Placebo in Patients With Chronic Low Back Pain
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will test an experimental drug called OROS® hydromorphone hydrochloride (HCl) (NMED-1077), a once daily opioid analgesic that can relieve pain. A large number of clinical studies have been conducted to test this drug. OROS hydromorphone HCl is currently approved in both the US and Europe to treat chronic pain. The purpose of this study is to compare OROS hydromorphone to placebo to see if it is safe and efficacious.
Timeline
- Start
- 2007-10
- Primary completion
- 2009-01
- Completion
- 2009-01
Publications
- Nalamachu S, Hale M, Khan A. Hydromorphone extended release for neuropathic and non-neuropathic/nociceptive chronic low back pain: a post hoc analysis of data from a randomized, multicenter, double-blind, placebo-controlled clinical trial. J Opioid Manag. 2014 Sep-Oct;10(5):311-22. doi: 10.5055/jom.2014.0221.
- Hale M, Khan A, Kutch M, Li S. Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain. Curr Med Res Opin. 2010 Jun;26(6):1505-18. doi: 10.1185/03007995.2010.484723.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydromorphone | Other / unclassified | 12 mg | Oral |
| Subject | Hydromorphone | Other / unclassified | 16 mg | Oral |
| Subject | Hydromorphone | Other / unclassified | 24 mg | Oral |
| Subject | Hydromorphone | Other / unclassified | 32 mg | Oral |
| Subject | Hydromorphone | Other / unclassified | 40 mg | Oral |
| Subject | Hydromorphone | Other / unclassified | 48 mg | Oral |
| Subject | Hydromorphone | Other / unclassified | 64 mg | Oral |