Conditions: Low Back Pain
Keywords: Low back pain Chronic pain Opioid Moderate to severe chronic low back pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1095
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Oxycodone/Naloxone Controlled-release Tablets (OXN) arm 2: Placebo tablets to match OXN

Interventions: intervention 1: Oxycodone/Naloxone Controlled-release intervention 2: Placebo
Intervention descriptions: intervention 1: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours intervention 2: Placebo tablets to match OXN taken orally every 12 hours

Protocol document: