Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)
Safety study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

OXYCODONE
NALOXONE HYDROCHLORIDE DIHYDRATE
TAPENTADOL

Medical condition to be studied

Back pain
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)

Estimated number of subjects

600
Study design details

Main study objective

Aim of this post-hoc analysis is to evaluate the tolerability and efficacy of oxycodone/naloxone PR vs. tapentadol PR – two different newer opioid-based analgesic treatment approaches, reported to be more efficacious for neuropathic pain than the conventional opioid agonists under real-life conditions. Primary hypothesis is a non-inferiority of both treatments with respect to the primary endpoint.

Outcomes

Primary outcome will be the percentage of patients (a) without adverse event-related study discontinuations who (b) maintained a normal bowel function (defined with the bowel function index) and (c) showed no treatment emergent adverse events affecting the central nervous system and (d) who presented with a combination of a ≥30% improvement of pain intensity, disability and quality-of-life. Percentages of patients with (a) a normal bowel function index, (b) changes in number of complete spontaneous bowel movements (CSBMs), (c) non CNS-related adverse events, (d) treatment-related changes in pain intensity, (e) disability and (f) quality-of-life.

Data analysis plan

Data analyses will be performed for all enrolled patients who took at least one dose of study medication and who had at least one post-baseline/post-dose measure (modified intent-to-treat approach). Analyses will be performed for three different patient samples to gain best insight into the real-life data and to avoid possible confounder/selection effects due to the open-label non-interventional study design: a) a random select approach – selecting patients on a pre-defined random list to eliminate possible selection effects, b) a matched paired-samples approach - selecting patients of both treatment groups according to their demographic and baseline pain characteristics to guarantee comparable baseline situations, and c) a whole data set approach – to take all observations made into consideration.