Effectiveness and tolerability of the THC:CBD oromucosal spray vs. typical oral long-term opioid-analgesics in patients with severe neuropathic (low) back pain: retrospective analysis of open-label real-world data provided by the German Pain e-Registry (NABILA-NBP)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

Study drug and medical condition

• Name of medicine, other:
  Sativex
• Study drug International non-proprietary name (INN) or common name:
  MORPHINE

  HYDROMORPHONE

  OXYCODONE
• Medical condition to be studied:
  Neuropathy peripheral
• Additional medical condition(s):
  Neuropathic (low) back pain

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1300

Study design details

• Main study objective:
  Main objective of this analysis is to gain further insight into the differential effects and the benefit-risk profile (BRP) of THC:CBD oromucosal spray vs. typical oral long-acting opioid-analgesics given add-on to patients with elsewhere refractory severe chronic neuropathic (low) back pain under real life conditions.
• Outcomes:
  Primary efficacy endpoint is an aggregated 9-factor symptom relief score (ASR-9) defined as a composite of nine efficacy parameters (at least 50% improvement of pain, pain-related disabilities in daily life, sleep, overall wellbeing, physical and mental quality-of-life, depression, anxiety and stress, each at end of observation vs. baseline). Secondary endpoint is the spectrum of treatment emergent adverse reactions (TEAEs) and the proportion of related treatment discontinuations.
• Data analysis plan:
  Exploratory analysis of anonymized 24-week routine/open-label data of the German Pain e-Registry (GPR) on adult NBP patients, in whom a treatment with THC:CBD oromucosal spray or with a typical oral long-acting-opioid analgesic (LAO) has been initiated in compliance with the current German prescribing regulations between March 10th and July 31st, 2020. No formal sample size analysis will be performed. Data analyses will be performed for all registered patients who took at least one dose of the THC/CBD oromucosal spray and comparable patients treated with LAO, who had at least one post-baseline/post-dose measure (modified intent-to-treat approach). Analyses will be performed only for patients with neuropathic (low) back pain identified with the modified 7-dimensional patient-reported pain detect questionnaire (PDQ7).