Conditions: Chronic Pain Low Back Pain Analgesia
Keywords: oxycodone naltrexone chronic pain low back pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 410
Healthy volunteers: no

Brief summary:
The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: ALO-02 intervention 2: Placebo
Intervention descriptions: intervention 1: 20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily intervention 2: oral placebo, divided into symmetric doses and administered twice daily

Protocol document: