REMS Retigabine Study

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

POTIGA is a trademark of Valeant Pharmaceuticals North America, used by GlaxoSmithKline under license.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Able to read, speak, and understand English.
Willing to take the online survey or have the survey administered via a telephone interview, including electronically signing a Confidentiality & Consent agreement and completing all study protocol-specified procedures.
Prescribed retigabine within the past 12 months (prescribing physicians)
Filled a prescription for at least one AED within the previous three months (pharmacists).

Exclusion criteria

Physicians or pharmacists meeting any of the following criteria will not be eligible to take the survey:
The physician or pharmacist is currently employed by, or is a representative of any of the following:
A pharmaceutical company or manufacturer of medicines or healthcare products.
Contributor/editor to published guideline committees for epilepsy or UR.
The physician or pharmacist has a visual impairment that would prevent him or her from being able to read independently.
The physician or pharmacist participated in the Pilot REMS study for retigabine.
The physician or pharmacist is an employee of GSK or Concentrics Research.

Treatment and study plan

Survey Responses

Other

Subject understanding of the risk of urinary retention and the symptoms of acute urinary retention associated with retigabine will be assessed using the survey instrument.

Primary 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.

Time frame: 12 months

The outcome is a survey response by physicians and pharmacists so is not related to the drug exposure.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

REMS Prescriber and Pharmacist Understanding of the Risk of Urinary Retention With POTIGA™

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Sep 10, 2013
Registry last updated: Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed