Open label, multinational, multicentre, prospective, real world observational study of Naloxegol for patients with cancer pain diagnosed with Opioid Induced Constipation (OIC). (NACASY)

Study type

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

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (A06AH03) naloxegol

  naloxegol
• Medical condition to be studied:
  Post procedural constipation

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:
  315

Study design details

• Main study objective:
  Incidence of adverse events leading to study discontinuation and response rate during the 4 weeks treatment period.
• Outcomes:
  Adverse events leading to study discontinuation and rate during the 4 weeks treatment period. Patients that have a BFI score changes Time to the first post-dose bowel movement. Change in stool consistency (Bristol stool scale). Change in Patient Assessment of Constipation (PAC-QOL) Incidence of overall adverse events and SAEs. Analgesic treatment interruptions/dose adjustments. Naloxegol treatment interruptions/dose adjustments. Patient satisfaction (PGI-I).
• Data analysis plan:
  The primary safety end point is the incidence of adverse events leading to study discontinuation. Number and percentage of patients who present an adverse event leading to study discontinuation and 95% CI will be provided. The primary efficacy end point is response rate during the 4 weeks treatment period. Response is defined as three or more bowel movements (without the use of rescue laxative treatment in the previous 24 hours) per week and an increase of one or more bowel movements over baseline. Response rate will be provided as frequency and 95% CI will also be presented. Exploratory and descriptive methods will be used to describe every study variable. Continuous variables will be described by mean, median, standard deviation, minimum and maximum. Categorical variables will be shown as distribution of frequencies and percentage.