Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

REMS Retigabine Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01938560
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : October 1, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

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.


Condition or disease Intervention/treatment
Epilepsy Other: Survey Responses

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

Layout table for study information
Study Type : Observational
Actual Enrollment : 1 participants
Time Perspective: Prospective
Official Title: REMS Prescriber and Pharmacist Understanding of the Risk of Urinary Retention With POTIGA™
Study Start Date : February 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Ezogabine

Group/Cohort Intervention/treatment
Physicians
Retigabine Physicians (e.g. neurologists/epileptologists/neurosurgeons) who have prescribed retigabine at least once in the last 12 months.
Other: Survey Responses
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.

Pharmacists
Pharmacists who have dispensed an anti-epileptic drug (AED) at least once in the last 3 months.
Other: Survey Responses
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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938560


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline

Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01938560     History of Changes
Other Study ID Numbers: 116490
WEUKBRE5993 ( Other Identifier: GSK )
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Layout table for MeSH terms
Ezogabine
Anticonvulsants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action