Trial reportPain research & management
Controlled-release oxycodone and naloxone in the treatment of chronic low back pain: a placebo-controlled, randomized study.
Trial report in Pain research & management. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 15 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 4 syntheses or guidelines pooled it, 52 citations in OpenAlex.
- Pooled it
- [Long-term opioid therapy in chronic noncancer pain. A systematic review and meta-analysis of efficacy, tolerability and safety in open-label extension trials with study duration of at least 26 weeks].Schmerz (Berlin, Germany) · 2015Pooled it
- [Opioids in chronic low back pain. A systematic review and meta-analysis of efficacy, tolerability and safety in randomized placebo-controlled studies of at least 4 weeks duration].Schmerz (Berlin, Germany) · 2015Pooled it
- Opioids compared to placebo or other treatments for chronic low-back pain.The Cochrane database of systematic reviews · 2013Pooled it
- Effectiveness of Opioids for Low Back Pain: A Systematic Review of Randomised Controlled Trials.Cureus · 2026Review
- Article
- Effects of pharmacotherapy on sleep-related outcomes in adults with chronic low back pain: A systematic review and meta-analysis of randomised controlled trials.EClinicalMedicine · 2023Article
- An Updated Overview of Low Back Pain Management.Asian spine journal · 2022Article
- Rescaling pain intensity measures for meta-analyses of analgesic medicines for low back pain appears justified: an empirical examination from randomised trials.BMC medical research methodology · 2022Article
- Pharmacotherapy for Spine-Related Pain in Older Adults.Drugs & aging · 2022Review
- Physical Compatibility and Chemical Stability of Fentanyl and Naloxone Hydrochloride in 0.9% Sodium Chloride Injection Solution for Patient-Controlled Analgesia Administration.Drug design, development and therapy · 2020Article
- An Updated Overview of Low Back Pain Management in Primary Care.Asian spine journal · 2017Review
- Emerging therapies for patients with symptoms of opioid-induced bowel dysfunction.Drug design, development and therapy · 2015Review
- Oxycodone/Naloxone: role in chronic pain management, opioid-induced constipation, and abuse deterrence.Pain and therapy · 2014Article
- Review
Corrections and comments
- Erratum issuedDosage error in article text
Authors and funding
14 authors at 7 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFor Canadian regulatory purposes, an analgesic study was required to complement previously completed, pivotal studies on bowel effects and analgesia associated with controlled-release (CR) oxycodone⁄CR naloxone.
objectivesTo compare the analgesic efficacy and safety of CR oxycodone⁄CR naloxone versus placebo in patients with chronic low back pain.
methodsPatients requiring opioid therapy underwent a two- to seven-day opioid washout before being randomly assigned to receive either 10 mg⁄5 mg CR oxycodone⁄CR naloxone or placebo every 12 h, titrated weekly according to efficacy and tolerability to 20 mg⁄10 mg, 30 mg⁄15 mg or 40 mg⁄20 mg every 12 h. After four weeks, patients crossed over to the alternative treatment for an additional four weeks. Acetaminophen⁄codeine (300 mg⁄30 mg every 4 h to 6 h as needed) was provided as rescue medication.
resultsOf the 83 randomized patients, 54 (65%) comprised the per-protocol population. According to per-protocol analysis, CR oxycodone⁄CR naloxone resulted in significantly lower mean (± SD)pain scores measured on a visual analogue scale (48.6 ± 23.1 mm versus 55.9 ± 25.4 mm; P=0.0296) and five-point ordinal pain intensity scores (2.1 ± 0.8 versus 2.4 ± 0.9; P=0.0415) compared with placebo. After the double-blinded phase, patients and investigators both preferred CR oxycodone⁄CR naloxone over placebo. These outcomes continued in the 79% of patients who chose to continue receiving CR oxycodone⁄CR naloxone in a six-month, open-label evaluation.
conclusionsIn patients complying with treatment as per protocol, CR oxycodone⁄CR naloxone was effective for the management of chronic low back pain of moderate or severe intensity.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.