A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

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.

Timeline

Start

2012-06

Primary completion

2013-06

Completion

2013-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); ALO-02 To Placebo vs ALO-02 To ALO-02; p = 0.0114; Difference of LS Means -0.62 (95% CI -1.11 to -0.14); NCT01571362 ↗

paper Change in the mean NRS-Pain score from randomization baseline to the final 2 weeks of the treatment period was significantly different favoring ALO-02 compared with placebo (P = 0.0114). PMID 25993547 ↗

Publications

• Gimbel JS, Rauck RL, Bass A, Wilson J, Pixton G, Malhotra B, Wilson G, Wolfram G. Effects of naltrexone exposure observed in two phase three studies with ALO-02, an extended-release oxycodone surrounding sequestered naltrexone. J Opioid Manag. 2019 Sep/Oct;15(5):417-427. doi: 10.5055/jom.2019.0530.
• Wilson JG, Bass A, Pixton GC, Wolfram G, Rauck RL. Safety and tolerability of ALO-02 (oxycodone hydrochloride and sequestered naltrexone hydrochloride) extended-release capsules in older patients: a pooled analysis of two clinical trials. Curr Med Res Opin. 2020 Jan;36(1):91-99. doi: 10.1080/03007995.2019.1661679. Epub 2019 Sep 17.
• Weil AJ, Masters ET, Barsdorf AI, Bass A, Pixton G, Wilson JG, Wolfram G. Patient-reported health-related quality of life, work productivity, and activity impairment during treatment with ALO-02 (extended-release oxycodone and sequestered naltrexone) for moderate-to-severe chronic low back pain. Health Qual Life Outcomes. 2017 Oct 17;15(1):202. doi: 10.1186/s12955-017-0749-y.
• Rauck RL, Hale ME, Bass A, Bramson C, Pixton G, Wilson JG, Setnik B, Meisner P, Sommerville KW, Malhotra BK, Wolfram G. A randomized double-blind, placebo-controlled efficacy and safety study of ALO-02 (extended-release oxycodone surrounding sequestered naltrexone) for moderate-to-severe chronic low back pain treatment. Pain. 2015 Sep;156(9):1660-1669. doi: 10.1097/j.pain.0000000000000230.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ALO-02	Unknown	—	Oral

Indications