Last updated: 11/07/2018 10:31:16

REMS Retigabine Study

GSK study ID
116490
See study documents
Clinicaltrials.gov ID
NCT01938560
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: REMS Prescriber and Pharmacist Understanding of the Risk of Urinary Retention with POTIGA™
Trial 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
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.

Timeframe: 12 months

Secondary outcomes:
Not applicable
Interventions:
  • Other: Survey Responses
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    L Ishihara, M Beck, S Travis, O Akintayo, N Brickel.Physician and pharmacist understanding of the risk of urinary retention with retigabine (ezogabine): A REMS assessment survey.Drugs Reald World Outcomes.2015;2(4):335-344.
    Medical condition
    Epilepsy
    Product
    retigabine
    Collaborators
    Not applicable
    Study date(s)
    February 2013 to May 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    Yes
    • 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.
    • 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:
    Inclusion and exclusion 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2013-28-05

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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