Trobalt™ Products Risk Survey
European Survey of Patient and Prescriber Understanding of Risks Associated With Trobalt™
As part of a European post-marketing commitment, GSK will conduct a survey of physicians' and patients' understanding of the significant risks associated with Trobalt™ (retigabine), as described in the Patient Information Leaflet (PIL) and the Physician's Guide. The goal of the surveys is to evaluate the effectiveness of the educational plan as specified in the European Risk Management Plan (RMP).
The objectives of this study are to assess patients' and prescribers' understanding and knowledge of the significant risks associated with Trobalt™ use as evaluated by a survey instrument.
This is a cross sectional survey of:
- 250 patients recruited from across the following countries (United Kingdom, Sweden, Denmark, Switzerland, Spain, Slovakia and Norway) and up to 100 patients from Germany who are currently using or have filled a prescription for Trobalt™ at least once in the last 3 months.
- 200 neurologists who have prescribed an anti-epileptic drug (AED) at least once in the last 3 months, and who were on the list to which a letter containing the Physician's Guide for Trobalt™ was distributed from across the following countries (United Kingdom, Sweden, Denmark, Switzerland, Spain, Slovakia and Norway). At least 75 of the neurologists will have prescribed Trobalt™. The survey will also aim to include up to 100 neurologists from Germany of which approximately 50 will have prescribed Trobalt™.
Patients eligible for the survey will be asked to take the survey online or via a telephone interview if the latter is preferred. Neurologists will be invited to take the survey online.
The selected countries were the first five countries to launch Trobalt™ (Germany, Denmark, United Kingdom, Switzerland and Sweden) and an additional three countries with launch in 2011, but with relatively high rates of uptake of Trobalt™ (Spain, Slovakia and Norway). The selection of countries includes Switzerland, which is not part of the European Union. However, the key messages regarding the risks with Trobalt™ are in alignment. The rationale for surveying the first five countries to launch is so that any issues identified from these countries regarding the effectiveness of the Physician's Guide and PIL in communicating the risks of Trobalt™ can be addressed as soon as possible, and the key messages can be revised in a timely manner. In addition, these countries are likely to provide the greatest number of neurologists with experience of prescribing Trobalt™, and their patients.
The primary outcome of the survey is the proportion of patients/neurologists providing correct responses to a series of questions concerning the significant risks associated with Trobalt™. The risks evaluated will be those described in the Trobalt™ PIL and in the Physician's Guide.
調査の概要
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
A random sample of 350 patients who are currently being treated with Trobalt™or who have received Trobalt™within the last 3 months. Patients will be recruited by prescribers, who will be asked to provide survey invitations to their patients being treated with Trobalt™.
A random sample of 300 neurologists prescribing anti-epileptic drug (AEDs) and who have been sent the Trobalt™ Physician's Guide. A sample of 200 neurologists will be recruited from across the same eight countries, with up to 100 neurologists from Germany. The recruitment will be from among those who have prescribed an AED at least once in the last 3 months, and who were on the list to which a letter including the Physician's Guide Trobalt™ was distributed. The survey will aim to recruit at least 75 physicians (from the seven specified countries) and 50 physicians from Germany with experience of prescribing Trobalt™ for sub-analyses, as these individuals would be expected to be more aware of the risks of Trobalt™.
説明
Inclusion Criteria:
Patients will be required to meet all the following inclusion criteria:
- Use of Trobalt™: current use or at least one prescription filled within the previous three months.
- 18 years of age or older.
- Willing to take the online survey or have the survey administered via a telephone interview.
Physicians will be required to meet all the following inclusion criteria:
- Must have prescribed an AED at least once in the last 3 months
- Must be on the list to which the Physician's Guide for Trobalt™ was distributed.
Exclusion Criteria:
Patients meeting any of the following criteria will not be eligible to take the survey:
- Unable to understand and complete the survey by internet or phone.
- Currently an employee of GSK or UBC.
Physicians meeting any of the following criteria will not be eligible to take the survey:
- Currently an employee of GSK or UBC.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
Patients using Trobalt™
Use of Trobalt™ current use or at least one prescription filled within the previous three months.
|
Trobalt™ is a potassium channel opener used as an adjunctive treatment for partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalization in adults aged 18 years and above with epilepsy.
|
Physicians prescribing AEDs
Physicians (neurologists) who prescribed AEDs at least once in the three months prior to the survey.
|
Trobalt™ is a potassium channel opener used as an adjunctive treatment for partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalization in adults aged 18 years and above with epilepsy.
|
Physicians Prescribing Trobalt™
Physicians (neurologists) who have had experience of prescribing Trobalt™ specifically, from among those who have prescribed AEDs at least once in the three months prior to the survey.
|
Trobalt™ is a potassium channel opener used as an adjunctive treatment for partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalization in adults aged 18 years and above with epilepsy.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
The proportion of patients/neurologists providing correct responses to a series of questions concerning the significant risks associated with Trobalt™ The risks evaluated will be those described in the Trobalt™ PIL and in the Physician's Guide.
時間枠:2 years
|
2 years
|
協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 116771
- WEUKBRE5744 (その他の識別子:GSK)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Trobalt™の臨床試験
-
Asklepios Kliniken Hamburg GmbHUniversity of Kiel完了気道管理 | ラリンジアル マスク エアウェイ | 光ファイバー挿管
-
Medtronic CardiovascularMedtronic完了
-
London Health Sciences CentreUniversity of Western Ontario, Canada; Synaptive Medicalわからない脳損傷、慢性 | Cerebellar Cognitive Affective Syndrome | 小脳無言症
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Andrew ParrentUniversity of Western Ontario, Canada; Synaptive Medicalわからない側頭葉てんかん
-
Boston Scientific Corporation完了一過性脳虚血発作 | 血栓塞栓性脳卒中 | 脳卒中予防アメリカ, アルゼンチン, ドイツ
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Medtronic Cardiovascular積極的、募集していない大動脈瘤ドイツ, ニュージーランド, アメリカ, オランダ, スイス, イギリス, スペイン, オーストラリア, イタリア, スウェーデン, フランス, オーストリア, スロバキア
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CereVasc IncAlvaMed, Inc.; Simplified Clinical Data Systems, LLC; Bioscience Consulting, Inc.募集