Risk of Urinary Retention With Retigabine

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01462656
First received: July 21, 2011
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Epilepsy
Drug: Non-EZG containing AED polytherapy
Drug: EZG containing AED polytherapy
Drug: Non-EZG AED monotherapy
Drug: EZG AED monotherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post Marketing Surveillance Study to Monitor the Risk of Urinary Retention in Retigabine Users

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. [ Time Frame: 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The risk and time to onset of UR among patients using EZG vs. non-EZG AED polytherapy [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
  • The risk of UR associated with post-marketing use of EZG under circumstances not indicated in the product label [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
  • The risk of UR among non-EZG AED monotherapy patients and the differential risk in UR for monotherapy versus polytherapy-treated patients [ Time Frame: 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1
Study Start Date: February 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with urinary retention
Patients with urinary retention
Drug: Non-EZG containing AED polytherapy
AED polytherapy without EZG
Drug: EZG containing AED polytherapy
AED polytherapy including EZG
Drug: Non-EZG AED monotherapy
AED monotherapy without EZG
Drug: EZG AED monotherapy
Any off-label use of EZG as monotherapy

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study cohorts of interest will be identified from the HealthCore Integrated Research Database (HIRD). The HIRD contains fully adjudicated paid claims from the largest commercially insured population in the US, with dates of service for all non-capitated ambulatory, emergency department, inpatient, and outpatient encounters (including administrative claims for laboratory tests) for members with eligibility at the time of service.

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:

      • 345 Epilepsy and recurrent seizures
      • 780.3 Convulsions
      • 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:

      • 345 Epilepsy and recurrent seizures
      • 780.3 Convulsions
      • 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462656

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01462656     History of Changes
Other Study ID Numbers: 115981, WEUKSTV4551, EPI40621
Study First Received: July 21, 2011
Last Updated: July 3, 2014
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
anti-epileptic drug
ezogabine
AED polytherapy
epilepsy
AED monotherapy
retigabine
urinary retention

Additional relevant MeSH terms:
Epilepsy
Urinary Retention
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Urination Disorders
Urologic Diseases
Ezogabine
Anticonvulsants
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014