Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Survey Responses
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: REMS Prescriber and Pharmacist Understanding of the Risk of Urinary Retention With POTIGA™
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.
Read the detailed description
POTIGA is a trademark of Valeant Pharmaceuticals North America, used by GlaxoSmithKline under license.
- Conditions
- Epilepsy
- Being tested
- Survey Responses
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey ResponsesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Physicians | Retigabine Physicians (e.g. neurologists/epileptologists/neurosurgeons) who have prescribed retigabine at least once in the last 12 months. Receives: Other: Survey Responses | |
| Pharmacists | Pharmacists who have dispensed an anti-epileptic drug (AED) at least once in the last 3 months. Receives: Other: Survey Responses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startFeb 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938560
- Sponsor's protocol ID
- 116490
- Other IDs
- WEUKBRE5993
- Status last verified
- Sep 2014
- First submitted
- 5 Sep 2013
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REMS Prescriber and Pharmacist Understanding of the Risk of Urinary Retention With POTIGA™
- ClinicalTrials.gov ID
- NCT01938560
- Acronym / sponsor ID
- 116490
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
POTIGA is a trademark of Valeant Pharmaceuticals North America, used by GlaxoSmithKline under license.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physicians | – | Other: Survey ResponsesRetigabine Physicians (e.g. neurologists/epileptologists/neurosurgeons) who have prescribed retigabine at least once in the last 12 months. |
| Pharmacists | – | Other: Survey ResponsesPharmacists who have dispensed an anti-epileptic drug (AED) at least once in the last 3 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey ResponsesSubject understanding of the risk of urinary retention and the symptoms of acute urinary retention associated with retigabine will be assessed using the survey instrument. | Other | Pharmacists, Physicians |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014.