NON-INTERVENTIONAL RETROSPECTIVE EVALUATION OF TOLERABILITY AND EFFICACY OF THE ATYPICAL WHO-STEP III OPIOIDANALGESIC TAPENTADOL PR UNDER REAL-WORLD CONDITIONS IN PATIENTS SUFFERING FROM (LOW) BACK PAIN AFTER FAILURE OF EITHER NONOPIOID, MILD OR STRONG OPIOID ANALGESICS (123TOTAP)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Tolerability
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Non-randomised clinical trial

Population studied

• Short description of the study population:
  Patients with low back pain (LBP) who were previously treated with either nonopioids (group 1), mild (group 2) or strong opioid analgesics (group 3) under conditions of routine clinical practice.
• 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:
  756

Study design details

• Main study objective:
  To assess differential treatment effects reported by patients who were switched to the target treatment after failure of a treatment with either a) nonopioids, b) mild opioids, or c) strong opioid analgesics
• Outcomes:
  Percentage of patients in all 3 treatment groups who fulfilled the criteria of an aggregated 5-factor symptom score (ASR-5), defined as a composite of four efficacy parameters (≥50% improvement of pain, pain-related disabilities, clinical phenomenology, and quality-of-life) and one tolerability parameter (≤12mm VAS – worsening of the bowel function). Percentage of patients in all 3 treatment groups who fulfilled at least three out of the five criteria of the ASR-5. Further analyses focus on treatment-related changes of pain intensity and associated parameters relevant for daily life functioning, quality-of-life, clinical pain phenomenology, concurrent analgesic treatments, bowel function and adverse events.
• Data analysis plan:
  Exploratory analysis of anonymized 12-week routine/open-label data provided by the German Pain e-Registry (GPR) on adult LBP patients, in whom a treatment with Tapentadol has been initiated in compliance with the current German prescribing regulations before November 30, 2017. LBP-patients who were switched to Tapentadol after failure of nonopioids were defined as group 1 and distinct baseline characteristics of this group (i.e. age, gender, severity of disease and stage of chronification) were taken as matching parameters for a propensity score analysis to find comparable pairs of patients who were switched to Tapentadol either after failure of mild (group 2) or strong opioid analgesics (group 3).No formal sample size analysis will be performed. Data analyses will be performed for all patients identified through the aforementioned selection process.