drugset / Trial / NCT01427270
Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and OIC who require around-the-clock opioid therapy.
Timeline
- Start
- 2011-08
- Primary completion
- 2014-10
- Completion
- 2014-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naloxone | Small molecule | 5 mg | Oral |
| Subject | Naloxone | Small molecule | 20 mg | Oral |
| Subject | Oxycodone | Other / unclassified | 10 mg | Oral |
| Subject | Oxycodone | Other / unclassified | 40 mg | Oral |
Indications
No indication recorded.