drugset / Trial / NCT01427283
A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy.
Timeline
- Start
- 2011-08
- Primary completion
- 2014-10
- Completion
- 2014-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Oxycodone | Other / unclassified | 10 mg | Oral |
| Comparator | Oxycodone | Other / unclassified | 40 mg | Oral |
| Subject | Oxycodone/Naloxone | Unknown | 10 mg | Oral |
| Subject | Oxycodone/Naloxone | Unknown | 40 mg | Oral |
Indications
No indication recorded.