DIFFERENTIAL GASTROINTESTINAL EFFECTS OF WHO-STEP III OPIOIDS IN LOW BACK PAIN PATIENTS WITH VS. WITHOUT CONSTIPATION: POST-HOC ANALYSIS OF DATA FROM A 12-WEEK PROSPECTIVE, OPEN-LABEL BLINDED ENDPOINT STREAMLINED STUDY (PROBE-PHA2)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Not applicable
• Scope of the study:
  Safety study (incl. comparative)
• If ‘Not applicable’, further details on the study type:
  Post-hoc analyses of existing data
• Data collection methods:
  Secondary use of data

Study drug and medical condition

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

  OXYCODONE

  NALOXONE HYDROCHLORIDE DIHYDRATE
• Medical condition to be studied:
  Back pain

Population studied

• Short description of the study population:
  Chronic low back pain (LBP) patients refractory to WHO-step I and/or II analgesics treated with WHO-step III opioids.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with chronic low back pain
• Estimated number of subjects:
  901

Study design details

• Main study objective:
  Main objective of this post-hoc analyses is to evaluate the differential dynamics of different WHO-step III opioid-analgesics on bowel function in patients with vs. without an already established non-opioid-related constipation under real life conditions.
• Outcomes:
  Primary criterion for this analysis is the treatment contrast for the frequency of patients with a ≥1 decline in the number of CSBMs per week. Secondary tolerability aspects are the percentages of patients (a) experiencing a clinically relevant BFI worsening (i.e. an increase ≥12 mm VAS) or (b) with a ≥50% BFI worsening vs. baseline, (c) with ≤3 CSBMs per week, and (d) with prescribed laxatives, each at the end of the 12-week observation period.
• 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. Linear interpolation / last observation carried forward (LOCF) method to impute missing scores. For continuous variables, descriptive statistics will be summarized by the number of patients (n), the mean, standard deviation (SD), 95% confidence intervals (95%-CI) of the mean, median, and range (minimum –maximum) values. For categorical and ordinal variables data will be summarized by frequency number (n) and percentage (%) of participants in each category, where appropriate, 95% confidence intervals are added. For between groups comparisons of continuous/categorical variables, Student t / Pearson's chi-squared test, for within group (e.g. pre-post) comparisons paired samples t-tests will be performed.

Documents

Study publications

Ueberall MA, Mueller-Schwefe GH. Differential Gastrointestinal Effects of Who-S…