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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40745
• EU PAS number:
  EUPAS4851
• Study ID:
  40745
• Official title and acronym:
  Prescriber and Pharmacist Understanding of the Risk of Urinary Retention with POTIGA (116490)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  As part of a post-marketing commitment, GSK will conduct a survey of prescribers’ and pharmacists’ understanding of the risk of urinary retention with retigabine products. This is to address the effectiveness of the Risk Evaluation and Mitigation Strategy (REMS) as outlined in the REMS approved by the FDA on 10th June 2011. 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. This is a cross-sectional study of approximately 200 physicians (e.g. neurologists/epileptologists/neurosurgeons) who have prescribed retigabine at least once in the last 12 months, and 200 pharmacists who have dispensed an anti-epileptic drug (AED) at least once in the last 3 months. The primary outcome of the survey is 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. The risks captured will be those described in the retigabine Dear Healthcare Provider (DHCP) letters, specifically risks of urinary retention. POTIGA is a trademark of Valeant Pharmaceuticals North America LLC, used by GlaxoSmithKline under license.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned: 14/02/2012

Actual: 14/02/2012

Study start date

Planned: 31/03/2013

Actual: 25/02/2013

Date of final study report

Planned: 12/10/2014

Actual: 28/05/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline LLC

Study protocol

Initial protocol

Prot-Amend2-STD-WEUKBRE5993-P_116490_LI_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)