A real world evidence study from Germany on the safety and efficacy of tapentadol and typical oral long-acting opioid analgesics in chronic low back pain patients (1o2toTAPoLAO)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Pain
• Additional medical condition(s):
  Chronic low back pain

Population studied

• Short description of the study population:
  Patients with chronic low back pain.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Chronic low back pain patients
• Estimated number of subjects:
  4500

Study design details

• Main study objective:
  To assess differential treatment effects reported by chronic plow back pain patients who were switched to the index drugsafter failure of a treatment with either nonopioids or mild opioid analgesics
• Outcomes:
  Responder analysis, i.e. percentage of patients who reported for pain intensity, daily life activities and physical/mental QoL absolute improvements ≥MCID and BFI changes ≤MCID (all after 12 weeks of treatment) and who didn´t stopped index treatment due to adverse drug-related events, Pain related sleep impairment assessed using the mPDI subscale and meeting the MCID, pain related sick leave as an absolute value using von Korff questionnaire, reason for discontinuation of index medication (TAP or LAO)
• Data analysis plan:
  Exploratory analysis of anonymized 12-week routine/open-label real-world data provided by the German Pain e-Registry (GPeR) on adult patients with chronic low back pain, in whom a treatment with Tapentadol or typical oral long-acting opioid analgesics has been initiated in compliance with the current German prescribing regulations before December 31, 2019. cLBP-patients have to be switched to index medication after failure of either nonopioid (WHO step 1) or mild opioid (WHO step 2) analgesics. Selection of treatment cases will base on a propensity score analysis (nearest neighbour technique, caliper 0.15, etc.) based on age, gender, baseline BFI, baseline pain (VAS), duration of current pain symptoms, comorbidities, previous and current pain medication group. No formal sample size analysis will be performed. Data analyses will be performed for all patients identified through the aforementioned selection process.