drugset
drugset / Trial / NCT01358526

Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain

NCT01358526 ↗

Phase 3 Completed 1095 enrolled Purdue Pharma LP
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of this study is to assess the efficacy and safety of OXN compared to placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back pain who require around-the-clock opioid therapy.

Timeline

Start
2011-05
Primary completion
2012-10
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Naloxone Small molecule 5 mg Oral
Subject Naloxone Small molecule 10 mg Oral
Subject Naloxone Small molecule 15 mg Oral
Subject Naloxone Small molecule 20 mg Oral
Subject Oxycodone Other / unclassified 10 mg Oral
Subject Oxycodone Other / unclassified 20 mg Oral
Subject Oxycodone Other / unclassified 30 mg Oral
Subject Oxycodone Other / unclassified 40 mg Oral

Indications

No indication recorded.