REMS Retigabine Study

NCT01938560 | Completed

• 2 other identifiers: 116490WEUKBRE5993
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (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.

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

  12 months

Study Arms (2)

Physicians

Retigabine Physicians (e.g. neurologists/epileptologists/neurosurgeons) who have prescribed retigabine at least once in the last 12 months.

Other: Survey Responses

Pharmacists

Pharmacists who have dispensed an anti-epileptic drug (AED) at least once in the last 3 months.

Other: Survey Responses

Interventions

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.

Pharmacists; Physicians

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 10, 2013
• Study Start: February 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 1, 2014

Record last verified: 2014-09