Last updated: 11/03/2018 18:42:32

Risk of urinary retention with retigabine

GSK study ID
115981
See study documents
Clinicaltrials.gov ID
NCT01462656
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A post marketing surveillance study to monitor the risk of urinary retention in retigabine users
Trial description: A prospective cohort study of antiepileptic drug (AED) polytherapy-treated epilepsy patients within the HealthCore Integrated Research Database (HIRD) will be conducted. Following the launch of Ezogabine (EZG), patients initiating a new AED polytherapy regimen will be followed until the earliest of an episode of urinary retention (UR), change in their AED regimen, end of follow-up, or end of study (when the specified sample size of EZG AED polytherapy users has been attained). After the end of study, the incidence of UR during exposures to EZG and non-EZG AED polytherapies will be compared. Polytherapy will be defined as treatment regimen containing at least two different AEDs.
A prospective cohort study of patients who receive EZG under circumstances not indicated in the product label within the HIRD will also be conducted. Following the launch of EZG, epilepsy patients initiating AED monotherapy with EZG as well as non-epilepsy patients initiating EZG for another disease will be followed until the earliest of an episode of UR, change in their AED regimen (if applicable), end of follow-up, or end of study. The incidence of UR during exposure to EZG under circumstances not indicated in the product label will be described. A descriptive analysis of the patients will also be included.
To meet the other secondary objective, non-EZG AED monotherapy users will be identified in the prospective cohort and incidence of UR will be calculated to determine if there is a difference in UR risk between monotherapy and polytherapy AED use.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

The risk and time to onset of UR associated with post-marketing use of EZG AED polytherapy, and the incremental risk compared with non-EZG AED polytherapy use.

Timeframe: From initiation of a new AED polytherapy regimen, until the earliest of an episode of UR, change in their AED regimen, end of follow-up, or end of study, whichever comes first, assesed up to three years.

Secondary outcomes:

The risk and time to onset of UR among patients using EZG vs. non-EZG AED polytherapy

Timeframe: From initiation of a new AED polytherapy regimen, until the earliest of an episode of UR, change in their AED regimen, end of follow-up, or end of study, whichever comes first, assesed up to three years.

The risk of UR associated with post-marketing use of EZG under circumstances not indicated in the product label

Timeframe: From initiation of a new AED polytherapy regimen, until the earliest of an episode of UR, change in their AED regimen, end of follow-up, or end of study, whichever comes first, assesed up to three years.

The risk of UR among non-EZG AED monotherapy patients and the differential risk in UR for monotherapy versus polytherapy-treated patients

Timeframe: From initiation of a new AED monotherapy regimen, until the earliest of an episode of UR, change in their AED regimen, end of follow-up, or end of study, whichever comes first, assesed up to three years.

Interventions:
  • Drug: Non-EZG containing AED polytherapy
  • Drug: EZG containing AED polytherapy
  • Drug: Non-EZG AED monotherapy
  • Drug: EZG AED monotherapy
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Epilepsy
    Product
    retigabine
    Collaborators
    Not applicable
    Study date(s)
    February 2011 to August 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Inclusion Criteria:
    • Prospective Cohort (indicated use)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:

      • Prospective Cohort (indicated use)

      • Patients with at least one medical claim carrying an ICD-9 code for epilepsy. The following ICD-9 codes will be used to identify patients with epilepsy: o 345 Epilepsy and recurrent seizures o 780.3 Convulsions o 780.39 Other convulsions
      • Patients initiating a new AED monotherapy* or polytherapy** following the launch of EZG.
      • At least 6 months of continuous healthcare plan enrolment before initiation of the new AED (monotherapy or polytherapy) following the launch of EZG. This will allow an assessment of baseline co-morbidities and concomitant medication use.
      • Aged ≥18 years at initiation of the new AED (monotherapy or polytherapy).

      Prospective Cohort (non-indicated use)

      • Epilepsy patients initiating EZG AED monotherapy
      • Patients <18 years old initiating EZG for epilepsy
      • Patients initiating EZG for any reason other than epilepsy
      • Patients initiating EZG AED polytherapy with less than six months of continuous healthcare enrolment who were excluded from the cohort described under the primary objective

      Retrospective Cohort

      • Patients with at least one medical claim carrying an ICD-9 code for epilepsy in the three year period preceding the launch of EZG. The following ICD-9 codes will be used to identify patients with epilepsy: o 345 Epilepsy and recurrent seizures o 780.3 Convulsions o 780.39 Other convulsions
      • Patients initiating a new AED monotherapy* or polytherapy** regimen in the three year period preceding the launch of EZG. •At least 6 months of continuous healthcare plan enrolment before initiation of the new AED regimen (monotherapy or polytherapy) during the three year period preceding the launch of EZG. This will allow an assessment of baseline co-morbidities and concomitant medication use.
      • Aged ≥18 years at initiation of the new AED (monotherapy or polytherapy). *This will include patients substituting an AED monotherapy. **This will include patients switching from a monotherapy to polytherapy regimen and those substituting an AED within an existing polytherapy regimen.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    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
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    2016-10-08

    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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