Prescriber and Pharmacist Understanding of the Risk of Urinary Retention with POTIGA (116490)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Prospective study, observational survey

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  RETIGABINE
• Additional medical condition(s):
  Epilepsy- Adjunctive treatment of drug-resistant partial onset seizures, with or without secondary generalisation, in patients with epilepsy where other appropriate drug combinations have proved inadequate or have not been tolerated

Population studied

• Short description of the study population:
  Physicians and pharmacists were recruited from a demographically representative population who prescribe POTIGA and dispense POTIGA.
• 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:
  0

Study design details

• Main study objective:
  The objectives of this survey are to assess prescribers’ and pharmacists’ understanding of the risk of urinary retention and the symptoms of acute urinary retention potentially associated with retigabine use as evaluated by a survey instrument.
• Outcomes:
  The proportion of physicians and pharmacists providing correct responses to a series of questions concerning the risk of urinary retention and the symptoms of acute urinary retention that may be associated with retigabine.
• Data analysis plan:
  The population for analysis will comprise all physicians and pharmacists recruited into the study, meeting eligibility criteria as assessed in the survey screener, and completing the survey.The primary outcome is the proportion of HCPs answering each question of understanding of the risks associated with retigabine correctly. Point estimates for the proportion with correct responses, and associated 95% confidence intervals, will be calculated for each question about the awareness of risks of retigabine. In the case of multiple choice questions, the number and proportion of subjects reporting each response will also be provided.GSK considers a proportion (%) of correct responses of at least 80% for each individual question to represent sufficient subject understanding of the risks associated with retigabine.

Documents

Study results

gsk-116490-clinical-study-report-redact

WWE116490_final_report_Concentrics